MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER POLY

Catalog Number UNK HIP ACETABULAR LINER POLY

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Ossification (1428); Pain (1994)

Event Date 01/25/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.Initial reporter occupation: lawyer.Component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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

(b)(6) 2020 revision arthroplasty hip, both acetabular and femoral components.(no more info provided).(b)(6) 2022, medical records report the patient noted an audible noise with any hip movement starting (b)(6), and pain, with a deep burning sensation.Radiographs are reported to show asymmetric position of femoral head component within the acetabular component compatible with linear wear/displacement.On (b)(6) 2022, the patient had a revision arthroplasty to address left hip pain.Intraoperative findings included: fracture of left polyethylene liner, metallosis, and wear of the ceramic head.(sticker page 213 of 305) there was a discrepancy between medical record that notes a zimmer dual mobility was implanted and the part/lot numbers that were provided were depuy bi-mentum pe liner, pinnacle dual mobility liner, and depuy femoral head.6 weeks prior to the current surgery, the patient was revised to address heterotopic ossification.Cup doi: (b)(6) 2019.Head and liner doi: (b)(6) 2020 - dor: (b)(6) 2022 (left hip).

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.

• Brand Name: UNK HIP ACETABULAR LINER POLY
• Type of Device: ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16333673
• MDR Text Key: 309131407
• Report Number: 1818910-2023-03314
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

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 Catalogue Number: UNK HIP ACETABULAR LINER POLY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/09/2023
• Supplement Dates Manufacturer Received: 03/01/2023
• Supplement Dates FDA Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ACTIS COLLARED HIGH SIZE 5; PINNACLE SECTOR II CUP 48MM; UNK HIP ACETABULAR LINER POLY; UNK HIP FEMORAL HEAD CERAMIC
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female