MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US J-LOC TRL LIN NEUT 28 X 46; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number 960063000

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 09/05/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Examination of the device was bale to confirm the complaint.According to the information received, the j-loc trl lin neut 28 x 46 in question was used for duraloc making impossible for the trial to fit in the cup.Additionally, the trial presents scratches and nicks all over the surface.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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

This (b)(4) is related to (b)(4) which reports about the event which occurred after the primary surgery.This pc reports about the event which occurred in the revision surgery.It was reported that on (b)(6) 2022, the patient underwent the revision surgery for replacing the cup.In the revision surgery, the trial liner in question did not fit well against the cup.The size of the trial liner does not seem to be according to specifications.The surgery was completed successfully without any surgical delay.No further information is available.

• Brand Name: J-LOC TRL LIN NEUT 28 X 46
• Type of Device: HIP INSTRUMENTS : ACETABULAR TRIALS
• 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: 16036311
• MDR Text Key: 306501145
• Report Number: 1818910-2022-26039
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 12/22/2022

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 Catalogue Number: 960063000
• Device Lot Number: 939183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/1933
• 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