MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC STEM TRIAL EXTRACT; HIP INSTRUMENTS : FEMORAL TRIALS

Catalog Number 865226

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2018

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

It was reported that the pfc stem trial extractor bent using the case.No surgical delay.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Product complaint: (b)(4).

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may 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: PFC STEM TRIAL EXTRACT
• Type of Device: HIP INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic driv; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic driv; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7307539
• MDR Text Key: 101311873
• Report Number: 1818910-2018-54388
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295216766
• UDI-Public: 10603295216766
• 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,Followup,Followup
• Report Date: 02/12/2018

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: 865226
• Device Lot Number: TX6210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/01/2018
• Supplement Dates Manufacturer Received: 03/13/2018; 03/13/2018; 03/13/2018; 04/02/2018
• Supplement Dates FDA Received: 03/14/2018; 03/19/2018; 03/19/2018; 04/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2012
• 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