MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE 100 ACET CUP 54MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number 1217-01-054

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Primary surgery details.Hospital: (b)(6).Date: (b)(6) 2022.Patient: 57 yr old female.Implants available for return: no - hospital have sent away for independent analysis.Revision surgery details.Hospital: (b)(6).Date: (b)(6) 2023.Reason for revision: poly liner had flipped out of cup (see image of pre-revision surgery x ray attached).Patient presented to clinic with squeaking.During revision surgery there was localised metallurgy where the head had rubbed against pinnacle cup.

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 Description

Additional information received indicates that the affected side involved was the left hip and there was no surgical delay reported in this event.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device associated with this report was not returned to depuy synthes for evaluation.Review of the photo evidence provided found evidence of implant disassociation between the cup and liner.Contact between the cup and head implant is visible due to this disassociation, therefore, it is reasonable to conclude that implant noise and wear is present.The reported complaint condition was confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product code/lot code combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: PINNACLE 100 ACET CUP 54MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16752385
• MDR Text Key: 313487750
• Report Number: 1818910-2023-08081
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295008569
• UDI-Public: 10603295008569
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2023

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
• Device Operator: Health Professional
• Device Model Number: 1217-01-054
• Device Catalogue Number: 121701054
• Device Lot Number: 3643367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 04/18/2023; 06/23/2023
• Supplement Dates FDA Received: 04/20/2023; 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: C-STEM AMT SZ3 HI OFFSET.; DELTA CER HEAD 12/14 32MM +5.; PINN MAR NEUT 32IDX54OD.; PINNACLE 100 ACET CUP 54MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female