MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ZT TRIAL SLEEVE 20F LRG; HIP INSTRUMENTS : FEMORAL TRIALS

Model Number 2576-22-115

Device Problems Material Discolored (1170); Material Deformation (2976); Material Twisted/Bent (2981); Naturally Worn (2988); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 office sets instrument was worn and cannot read.No surgery was affected.

Manufacturer Narrative

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.Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

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.

Manufacturer Narrative

Product complaint(b)(4).Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: investigation summary : examination of the returned instrument confirmed the reported observation.The root cause is attributed to misuse and heavy usage.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.The device associated with this report was not returned.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Territory 226 reports that the office set instrument was worn and cannot read.The device associated with this report was not returned.Provided information states the instrument is worn.With no instrument returned and no more information, no root cause can be determined for this specific instrument.A lot specific complaint database search was not possible as the lot code required was not provided.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under post market surveillance sep 419.Update: (b)(6) 2019.Territory 226 reports that the office set instrument was worn and cannot read.Examination of the returned instrument confirmed the complaint; the trial is extremely worn and damaged.The trial exhibits numerous gouges, nicks, and scratches.Portions of the anodized coating is missing.Both sides of the trial are damaged.The side opposite of the lot information is extremely damaged due to misuse heavy usage.Damage can occur once the trial sleeves have been seated if any bone fragments/uneven surfaces exist from the earlier neck resection.It is suspected that users are leaving the trials in place when cleaning up / filing off any extra bone and in turn damaging the top surface of the trial sleeves.The root cause is attributed to misuse heavy usage.Based on the investigation, the need for corrective action is not indicated.Continue to monitor complaints under post market surveillance sep-419.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.Product complaint # : (b)(4).Investigation summary: examination of the returned instrument confirmed the reported observation.The root cause is attributed to misuse and heavy usage.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ZT TRIAL SLEEVE 20F LRG
• Type of Device: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8466338
• MDR Text Key: 140630168
• Report Number: 1818910-2019-89094
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295146919
• UDI-Public: 10603295146919
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2576-22-115
• Device Catalogue Number: 257620125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1