MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 UNK HIP ACETABULAR CUP DURALOC

Catalog Number UNK HIP ACETABULAR CUP DURALOC

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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 Description

The patient had her hip replaced in 2001.She had a duraloc cup and a replica stem.Recently, her replica stem broke in half.So doctor decided to perform revision surgery.The doctor was unable to remove the distal portion that broke off.So that stayed in the canal.Loosening of the replica stem is also indicated at bone to implant interface.Doi: 2001.Dor: december 14, 2023.Affected side: right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received: the patient had her hip replaced in 2001.She had a duraloc cup and a replica stem.Recently, her replica stem broke in half.So doctor decided to perform revision surgery.The doctor was unable to remove the distal portion that broke off.So that stayed in the canal.Loosening of the replica stem is also indicated at bone to implant interface.The product was not returned to depuy synthes, however photos were provided for review.See ((b)(4) device photo ad 19 dec 2023 (1), (b)(4) device photo ad 19 dec 2023 (2), (b)(4) device photo ad 19 dec 2023 (3), (b)(4) x-ray flims ad 15 dec 2023 (4).Jpg, (b)(4) x-ray flims ad 15 dec 2023 (5).Jpg, (b)(4) x-ray flims ad 15 dec 2023 (06).Jpg, (b)(4) x-ray flims ad 15 dec 2023 (07)jpg, (b)(4) x-ray flims ad 15 dec 2023 (08).Jpg, (b)(4) x-ray fillms ad 15 dec 2023, (b)(4) x-ray flims ad 15 dec 2023 (1), (b)(4) x-ray flims ad 15 dec 2023 (2), (b)(4) x-ray flims ad 15 dec 2023 (3)).The photo/x-ray investigation revealed that unk hip acetabular cup duraloc appears to be positioned more vertically and with more anteversion than recommended.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.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the unk hip acetabular cup duraloc would contribute to the complained device issue.Based on the investigation findings, a potential cause cannot be established and 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 device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: UNK HIP ACETABULAR CUP DURALOC
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18404049
• MDR Text Key: 331480121
• Report Number: 1818910-2023-26077
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

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 CUP DURALOC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: REPLICA SM STAT SHT RT 10.5MM.; UNKNOWN HIP ACETABULAR LINERS.
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female