MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN 100 W/GRIPTION 58MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number	121731058
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2025
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the patient had a hip surgery and came back after 8 weeks because the liner had luxaded out of the cup.Patient was revised.
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 hat 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: d10 (concomitant).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 = > according to the information provided: "patient that had a hip surgery and came back after 8 weeks because the liner had luxaded out of the cup".The product was not returned to depuy synthes, however photos were provided for review.See attachment (kalmar 1.Jpg, kalmar 2.Png and kalmar 3.Png).The photo/x-ray investigation was able to confirm the reported event, based on the damage observed on the pinn mar neut 32idx58od (liner) and the delta cer head 12/14 32mm +5 (head).Furthermore, in the x-ray evidence, the head was found not centered at the implantation site, confirming a disassociation between the liner and the cup.The reported allegation can be confirmed as the fracture on the anti-rotational mechanism of the liner and the metal transfer observed on the head are evidence that can be related to a dissociation condition between the liner and the pinn 100 w/gription 58mm (cup).However, consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations, patient changes over time and the extraction procedure.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.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 100 w/gription 58mm 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 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 as no lot number was provided for this device.If the lot/serial number becomes available, the record will be re-assessed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > according to the information provided: "patient that had a hip surgery and came back after 8 weeks because the liner had luxaded out of the cup".¿the product was not returned to depuy synthes, however photos were provided for review.See attachment (kalmar 1.Jpg, kalmar 2.Png and kalmar 3.Png).The photo/x-ray investigation was able to confirm the reported event, based on the damage observed on the pinn mar neut 32idx58od (liner) and the delta cer head 12/14 36mm +12 (head).Furthermore, in the x-ray evidence, the head was found not centered at the implantation site, confirming a disassociation between the liner and the cup.The reported allegation can be confirmed as the fracture on the anti-rotational mechanism of the liner and the metal transfer observed on the head are evidence that can be related to a dissociation condition between the liner and the pinn 100 w/gription 58mm (cup).However, consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations, patient changes over time and the extraction procedure.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.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 100 w/gription 58mm 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 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 as no lot number was provided for this device.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: PINN 100 W/GRIPTION 58MM
• 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 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23622344
• Report Number: 1818910-2025-20590
• Device Sequence Number: 9051650
• Product Code: KWA
• UDI-Device Identifier: 10603295010234
• UDI-Public: (01)10603295010234
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K090998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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

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: 121731058
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 01/26/2026; 02/11/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/07/2026; 01/28/2026; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 36MM +12.; PINN MAR +4 NEUT 32IDX58OD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown