MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 32IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121932052
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Discomfort (2330)
Date of Event	07/15/2024
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.
Event or Problem Description
Revision of liner at hospital.Liner and femoral head removed from the patient and replaced.Reason for revision: patient originally presented to an outpatient clinic due to discomfort in hip.Identified that the liner had become disengaged with the cup.Original surgery was in 2013.Intra-op notes: surgeon noted that the liner had come away from the cup completely, there was a fair amount of black tissue removed from the region around the acetabulum and this could also be seen on the cup.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product 121932052/lot 393494 combination.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product 121932052/lot 393494 combination.
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.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
Additional information was received and stated the liner and the head were removed.The cup was still in situ.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product 121932052/lot 393494 combination.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product 121932052/lot 393494 combination.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: revision of liner at [hospital].Liner and femoral head removed from the patient and replaced.Reason for revision: patient originally presented to an outpatient clinic in [date] due to discomfort in hip.Identified that the liner had become disengaged with the cup.Original surgery was in [year] with [surgeon] at [hospital].Original sizing was 52 pinnacle cup, 32/52 liner, size one c-stem and a 32/+5 femoral head (unable to collect details beyond this during the surgery).Intra-op notes: surgeon noted that the liner had come away from the cup completely, there was a fair amount of black tissue removed from the region around the acetabulum and this could also be seen on the cup.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the rim of the pinn mar neut 32idx52od has four out of six anti-rotation device (ard) tabs sheared off.The broken fragments were not returned for evaluation.Additionally, the liner appeared to have been edge loaded causing eccentric deformation in the rim of the device and ultimately contributing to the failure of the anti-rotation devices (ards).Based on the observations of the pinn mar neut 32idx52od, it is reasonable to conclude that a disassociation event occurred between the liner and the cup.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the liner 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 dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the pinn mar neut 32idx52od would have contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to component failure, and 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.

• Brand Name: PINN MAR NEUT 32IDX52OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 19826427
• Report Number: 1818910-2024-15905
• Device Sequence Number: 8728376
• Product Code: LPH
• UDI-Device Identifier: 10603295013907
• UDI-Public: (01)10603295013907(17)180531(10)393494
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 07/25/2024

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: 05/31/2018
• Device Catalogue Number: 121932052
• Device Lot Number: 393494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2024
• Supplement Date Received by Manufacturer: 08/15/2024; 11/13/2024; 11/26/2024; 01/09/2025
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/19/2024; 11/22/2024; 11/27/2024; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2013
• 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 36IDX52OD; DLT TS CER HD 12/14 36MM +8.5; UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP FEMORAL HEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown