MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 32IDX54OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122132054
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Acetabulum liner component revision due to original liner displacement.Original hip replacement operation took place (b)(6) 2023.Revision took place (b)(6) 2024.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: as the lot number for the device involved in the event was not provided, 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.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: acetabulum liner component revision, due to original liner displacement.Original hip replacement operation took place (removed date).Revision took place (removed date).The product was returned to depuy synthes for evaluation.Visual analysis of the returned device revealed, that the rim of the altrx neut 32idx54od, has five out of six anti-rotation device (ard) tabs sheared off.The broken fragments were not returned for evaluation.Additionally, deformation was observed on the rim.Based on the observations of the device and the returned femoral head, it is reasonable to conclude, that a disassociation event occurred, between the liner and the cup.Furthermore, scratches were identified, at the surface of the rim.Which do not allow to identified, the lot number.Most likely, caused by the extraction process.It is evident, that the edge of the liner was loaded by the femoral head and patient body weight, while implanted.There are machining lines from the manufacturing process yet visible within the liner, which would not be as obviously present had the femoral head been more centrally loaded.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 for the liner was unable to be performed, due to post manufacturing damage.The overall complaint was confirmed, as the observed condition of the altrx neut 32idx54od, would 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 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 records evaluation (mre) was not performed, since the lot number was not able to be retrieved for the device, due to the scratches.Corrected: d4: primary udi number.

• Brand Name: ALTRX NEUT 32IDX54OD
• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19250423
• Report Number: 1818910-2024-09945
• Device Sequence Number: 6438460
• Product Code: LPH
• UDI-Device Identifier: 10603295016120
• UDI-Public: (01)10603295016120
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 05/06/2024

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 Catalogue Number: 122132054
• 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: 04/24/2024
• Supplement Date Received by Manufacturer: 05/17/2024; 07/29/2024; 09/06/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/20/2024; 07/30/2024; 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: DELTA CER HEAD 12/14 32MM +1; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown