MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 TRIAL CORAIL REVISION STEM 11; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number L98511

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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 reports the trunnion that secures the neck trial to the stem trial was bent and the neck would not fully seat on the stem trial.Nothing affected the patient and no instruments were left behind.

Manufacturer Narrative

Product complaint #
=
> (b)(4) if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # pc-(b)(4).Investigation summary examination of the returned instrument confirmed the complaint.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: TRIAL CORAIL REVISION STEM 11
• Type of Device: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• 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: 7209093
• MDR Text Key: 97975767
• Report Number: 1818910-2018-51643
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295262596
• UDI-Public: 10603295262596
• 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,Followup
• Report Date: 01/02/2018

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: L98511
• Device Lot Number: SF1110501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2018
• Initial Date FDA Received: 01/22/2018
• Supplement Dates Manufacturer Received: 01/08/2018; 07/19/2018
• Supplement Dates FDA Received: 01/22/2018; 08/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR