MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121732054
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H3, h6 investigation summary: ¿the product was not returned to j&j medtech orthopaedics, however photos were provided for review.The x-ray investigation revealed that a disassociation occurred between the acetabular liner and the cup.The femoral head appears to be not centrally loaded since it can be observed that it is having a direct contact with the cup.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.If the lot/serial number becomes available, the record will be re-assessed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the pinn sector w/gription 54mm would have contributed to the complained device issue.¿ based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.A manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.If the lot/serial number becomes available, the record will be re-assessed.
Event or Problem Description
It was reported that the patient was scheduled for revision surgery due to liner disassociation.Surgeon will be removing and replacing the cup and liner.The operating surgeon feels there must be an issue with the locking mechanism for the cup.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d9, d10.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d9.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received and states that: could we also note that there is a marker pen line on the polyethylene liner showing where the surgeon used a kocher to remove the liner from the acetabulum after it had dissociated.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- patient referred to him on the trauma list due to a pinnacle liner disassociation.He will be removing and replacing the cup and liner.The cup and liner will be contaminated but available for return and analysis.The operating surgeon feels there must be an issue with the locking mechanism for the cup and would like this investigated.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the pinn sector w/gription 54mm has signs of what appears to be organic material adhered at the outer fixation surface, also the acetabular cup presents wear at the inner surface most likely caused by interaction with the femoral head after the disassociation event occurred.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A search of the j&j medtech orthopaedics nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the pinn sector w/gription 54mm would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot- a search of the j&j medtech orthopaedics nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.H11 additional narrative: corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > patient referred to him on the trauma list due to a pinnacle liner disassociation.He will be removing and replacing the cup and liner.The cup and liner will be contaminated but available for return and analysis.The operating surgeon feels there must be an issue with the locking mechanism for the cup and would like this investigated.The product was not returned to j&j medtech orthopaedics, however photos were provided for review.See attachment (b)(4)- liner disassociation lincoln county.The x-ray investigation revealed that a disassociation occurred between the acetabular liner and the cup.The femoral head appears to be not centrally loaded since it can be observed that it is having a direct contact with the cup.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A search of the j&j medtech orthopaedics nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the pinn sector w/gription 54mm would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = > a search of the j&j medtech orthopaedics nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Added: d4 (lot), h4 corrected: d4 (primary udi #).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: patient referred to him on the trauma list due to a pinnacle liner disassociation.He will be removing and replacing the cup and liner.The cup and liner will be contaminated but available for return and analysis.The operating surgeon feels there must be an issue with the locking mechanism for the cup and would like this investigated.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the pinn sector w/gription 54mm has signs of what appears to be organic material adhered at the outer fixation surface, also the acetabular cup presents wear at the inner surface most likely caused by interaction with the femoral head after the disassociation event occurred.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the cup locking mechanism failure cannot be traced to design or manufacturing, a definite root cause cannot be established due to there being multiple factors that may influence eccentric loading.Consideration must be given to all potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.It is highly recommended to the patient to consult with their healthcare professional for further assessment.A manufacturing record evaluation was performed for the finished device product description: pinn sector w/gription 54mm product code: 121732054 lot number: m8997z, and no non-conformances nor manufacturing irregularities were identified.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the pinn sector w/gription 54mm would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device product description: pinn sector w/gription 54mm product code: 121732054 lot number: m8997z, and no non-conformances nor manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: pinn sector w/gription 54mm product code: 121732054 lot number: m8997z, and no non-conformances nor manufacturing irregularities were identified.Added: d4 expiration date.Corrected: d4 primary udi number, h3.

• Brand Name: PINN SECTOR W/GRIPTION 54MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22725231
• Report Number: 1818910-2025-13742
• Device Sequence Number: 8344549
• Product Code: KWA
• UDI-Device Identifier: 10603295010319
• UDI-Public: (01)10603295010319(17)250331(10)M8997Z
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 121732054
• Device Lot Number: M8997Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 09/15/2025; 09/23/2025; 10/10/2025; 10/17/2025; 02/26/2026
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/17/2025; 09/24/2025; 10/15/2025; 10/17/2025; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICUL/EZE BALL 32 +5 BR.; ARTICUL/EZE BALL 32 +5 BR.; CORAIL AMT SZ13 135 HIGH COL.; CORAIL AMT SZ13 135 HIGH COL.; PINN MAR NEUT 32IDX54OD.; PINN SECTOR W/GRIPTION 54MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown