MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 28IDX46OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121928146
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent revision surgery due to premature wear of polyethylene.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary photographs were provided but they do not represent the current complaint condition or a device malfunction, example; photos of tags, photos of sticker sheets (and the allegation is unrelated to labeling), unrelated photos, etc.According to the information received, ¿the hcp request by the tpi a study of the following reference implemented in (name removed) on (b)(6)2021 ¿ dr.(name removed) ¿ private surgery ¿ episode e135263" the product was not returned to medtech orthopaedics; however, photos were provided for review.See attachment ¿incidencia poli ortoarins.Jpg¿.The investigation was not able to confirm the reported event as the complaint condition was not represented clearly in the provided photo.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs provided are not representative of the reported complaint condition.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 complaint condition.As part of 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 hcp request by the tpi a study of the following reference implemented in (name removed) on (b)(6) 2021 ¿ dr.(name removed) ¿ private surgery ¿ episode e135263.The product was returned to j&j medtech orthopaedics for evaluation additionally a material evaluation.Visual inspection of the liner was fractured in multiple locations, not all fragments were returned.There is deformation of the 10 degree lip suggesting impingement or subluxation.There is a fatigue fracture of the rim that likely initiated from the outer diameter surface between two anti-rotation device 'ards' at the locking mechanism within the 10 degree lip.There is a fatigue fracture through the articular surface of the liner, also initiating from the outer diameter surface, at the intersection of the locking mechanism and the rim fracture.Additionally the metal head shows substantial material transfer consistent with wear between the head and the titanium acetabular cup, suggesting the fractured liner disassociated from the cup at some time prior to revision surgery.Based on the observations of the pinn mar +4 10d 28idx46od and the returned articul/eze ball, 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 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.A manufacturing record evaluation was performed for the finished device product description: pinn mar +4 10d 28idx46od product code: 121928146 lot number: j23a71 and no non-conformances or manufacturing irregularities were identified.The overall complaint was confirmed as the observed condition of the pinn mar +4 10d 28idx46od would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.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 manufacturing record evaluation was performed for the finished device product description: pinn mar +4 10d 28idx46od product code: 121928146 lot number: j23a71 and no non-conformances or manufacturing irregularities were identified.Device history review: 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.H11 additional narrative: corrected: h3.

• Brand Name: PINN MAR +4 10D 28IDX46OD
• 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 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21282540
• Report Number: 1818910-2025-01825
• Device Sequence Number: 9319944
• Product Code: LPH
• UDI-Device Identifier: 10603295013440
• UDI-Public: (01)10603295013440(17)240131(10)J23A71
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 01/31/2024
• Device Catalogue Number: 121928146
• Device Lot Number: J23A71
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 03/25/2025; 03/28/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/26/2025; 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown