MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 10D 36IDX52OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121936152
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon revised (10th revision) a thr for pain and aseptic loosening.Non-synthes stem removed and non-synthes stem implanted.Depuy pinnacle cup was well fixed.+4/10 liner was removed and replaced with a new one.Minimal wear on the liner that was removed.Only replaced due to stem revision.Procedure was completed successfully with no delay.
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
Additional information was received and states that: ¿ can you please confirm if the patient had previous revision for removal of depuy stem? ¿ what was the reason for revision for the previous revision? ¿ was it reported? if yes, please share the pc number.¿ product details of the removed depuy stem? ¿ when was the revision? "i¿m sorry but i don¿t have all the details you are requesting.From what i remember this was possibly an asr metal on metal case and the stem was possibly a corail, still uses corail as his hip stem preference.I don¿t know the original reason for revision, but i do know 2 of the hip revisions were for abductor repair/reconstruction which could have possibly led to infection.I would assume the asr liner was removed when the stem was.I do not know if these products were reported.Unsure of any dates.".
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 recon described in this report.H11 additional narrative: added: b5.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary surgeon] revised (10th revision) a thr for pain and aseptic loosening.Stryker stem removed and zimmer stem implanted.Depuy pinnacle cup was well fixed.+4/10 liner was removed and replaced with a new one.Minimal wear on the liner that was removed.Only replaced due to stem revision.The product was not returned to depuy synthes; however, photos were provided for review.The photo investigation reveled that pinn mar +4 10d 36idx52od shows wear at the outer rim section.No other anomalies were noted.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, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the pinn mar +4 10d 36idx52od 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 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 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 +4 10D 36IDX52OD
• 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: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23605714
• Report Number: 1818910-2025-20417
• Device Sequence Number: 9444362
• Product Code: LPH
• UDI-Device Identifier: 10603295014577
• UDI-Public: (01)10603295014577(17)140201(10)DF3GC1000
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033273
• 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: 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: 02/01/2014
• Device Catalogue Number: 121936152
• Device Lot Number: DF3GC1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 11/25/2025; 01/28/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/01/2025; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2009
• 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: UNK HIP ACETABULAR CUP PINNACLE.; UNKNOWN FEMORAL STEM COMPETITOR (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female