MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 GLOBAL UNITE TR BODY SZ14 135; EXTREMITY INSTRUMENTS : PROXIMAL BODY TRIALS

Catalog Number 210050015

Device Problems Material Discolored (1170); Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

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

Der states that green ring around the neck of the size 14 humeral proximal body trial fluffed off in the patient during reduction trial.All pieces were recovered.No items remained in the patient.Surgery time was delayed only by the amount of time it took to recover green color "coating" from the patient.Surgeon identified instrument error early.There may be deficiency in the design but may be stress and number of times used.Surgeon performed extensive i&d.Intra-op images are available of the prosthesis trial.

Manufacturer Narrative

Review of the provided photographs confirm the reported event.The device associated with this report was not returned for evaluation.Depuy considers the investigation closed.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, will be filed as appropriate.

• Brand Name: GLOBAL UNITE TR BODY SZ14 135
• Type of Device: EXTREMITY INSTRUMENTS : PROXIMAL BODY TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7159739
• MDR Text Key: 96229677
• Report Number: 1818910-2018-50061
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295416098
• UDI-Public: 10603295416098
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

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: 210050015
• Device Lot Number: NW148536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 09/18/2018
• Supplement Dates FDA Received: 09/19/2018
• Date Device Manufactured: 02/11/2014
• 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
• Patient Age: 71 YR