MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ARTICUL TR BALL GRVD 36 +1.5; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number 2531-51-000

Device Problems Material Integrity Problem (2978); Naturally Worn (2988); Scratched Material (3020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2023

Event Type  malfunction  

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

It was reported that the instruments are blunt and needed to be upgraded.There was no delay in surgery.It was report today (b)(6) 2023.The heads are all scratched and damaged and the surgeon has complained.

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.

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 photographic evidence confirm, the reported allegation.The top surface of the device was found scratched and presents a heavy usage appearance.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a date code was provided.Which indicates, that the device was manufactured on 2009.A manufacturing records evaluation (mre) was not performed, since a valid finished good lot number was not provided for this device.

• Brand Name: ARTICUL TR BALL GRVD 36 +1.5
• Type of Device: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• 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: 16396557
• MDR Text Key: 310100704
• Report Number: 1818910-2023-03972
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295129189
• UDI-Public: 10603295129189
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2531-51-000
• Device Catalogue Number: 253151000
• Device Lot Number: DJ1109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 02/20/2023; 02/21/2023; 04/26/2023
• Supplement Dates FDA Received: 02/20/2023; 02/27/2023; 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2009
• 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