MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 50MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121701050
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Noise, Audible (3273)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Patient underwent right thr eighteen months prior.Procedure was completed with no problems.The patient had to be revised due to nine month history of clunking/subluxation and six day history of squeaking.X-ray showed liner dissociation.Intraoperatively, the liner spun inferiorly with head articulating with shell.
Additional Manufacturer Narrative
Product complaint #(b)(4).D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.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 (concomitant), h6 (medical device problem code).Corrected: d4 (lot, primary udi number).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).Investigation summary: the implant had ti be revised yesterday (b)(6) 2025 due to the below (please see surgeons explanation below).I have also attached the product details and a picture.From surgeon: right thr 18 months ago.No problems.9 month history of clunking/subluxation.6 day history of squeaking and x ray showed liner dissociation.Intraop liner spun inferiorly with head articulating with shell.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.The photo investigation revealed that the pinnacle 100 acet cup 50mm was covered with appears to be organic material at the outer fixation surface.Additionally, the acetabular cup presents signs of wear at the inner surface most likely caused by interaction with the femoral head after the disassociation event occurred.The observed disassociation could have contributed to the hip joint noise.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.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 pinnacle 100 acet cup 50mm 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the implant had ti be revised yesterday (b)(6) 2025 due to the below (please see surgeons explanation below).I have also attached the product details and a picture.From surgeon: right thr 18 months ago.No problems.9 month history of clunking/subluxation.6 day history of squeaking and x ray showed liner dissociation.Intraop liner spun inferiorly with head articulating with shell.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachment (b)(4) (b)(6) hospital.The photo investigation revealed that the pinnacle 100 acet cup 50mm was covered with appears to be organic material at the outer fixation surface.Additionally, the acetabular cup presents signs of wear at the inner surface most likely caused by interaction with the femoral head after the disassociation event occurred.The observed disassociation could have contributed to the hip joint noise.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.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 pinnacle 100 acet cup 50mm 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the implant had ti be revised yesterday (b)(6) 2025 due to the below (please see surgeons explanation below).I have also attached the product details and a picture.From surgeon: right thr 18 months ago.No problems.9 month history of clunking/subluxation.6 day history of squeaking and x ray showed liner dissociation.Intraop liner spun inferiorly with head articulating with shell.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the pinnacle 100 acet cup 50mm has signs of organic material adhered at the outer fixation surface, also the cup presents wear at the inner surface most likely caused by interaction with the femoral head after the disassociation event occurred.The observed disassociation could have contributed to the hip joint noise.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 dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.He overall complaint was confirmed as the observed condition of the pinnacle 100 acet cup 50mm 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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected: h3.

• Brand Name: PINNACLE 100 ACET CUP 50MM
• 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: 22749284
• Report Number: 1818910-2025-13898
• Device Sequence Number: 9672843
• Product Code: LPH
• UDI-Device Identifier: 10603295008545
• UDI-Public: (01)10603295008545(10)M25C86
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P070026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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 Catalogue Number: 121701050
• Device Lot Number: M25C86
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 08/19/2025; 08/27/2025; 08/28/2025; 09/22/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 08/25/2025; 08/28/2025; 09/02/2025; 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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: ALTRX NEUT 32IDX50OD.; APEX HOLE ELIM POSITIVE STOP.; CORAIL AMT COLLAR SIZE 14.; DELTA CER HEAD 12/14 32MM +5.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown