MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG TIB CEM STEM TRL 13X60 2-3; KNEE INSTRUMENT : TIBIAL STEM TRIALS

Model Number 86-6502

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 07/02/2020

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 sigma 13x60 cemented stem came off in femur while reaming for sleeve.It lodged in femur and surgeon could not get it out.It was implanted in patient.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with the reported event was not returned for evaluation.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H6 patient code: no code available (3191) used to capture the surgery prolonged and insufficient information.

• Brand Name: SIG TIB CEM STEM TRL 13X60 2-3
• Type of Device: KNEE INSTRUMENT : TIBIAL STEM TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10284212
• MDR Text Key: 199923693
• Report Number: 1818910-2020-16080
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295217220
• UDI-Public: 10603295217220
• Combination Product (y/n): N
• PMA/PMN Number: K955884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

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 Model Number: 86-6502
• Device Catalogue Number: 866502
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR