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 Problem Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 10/02/2020

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 a stem trial got stuck in the femur.The stem extractor we screwed into it broke off.No further information is available.Surgical delay of 10 minutes.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned and no investigational inputs were provided for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• 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: 10697122
• MDR Text Key: 211888414
• Report Number: 1818910-2020-22716
• 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: 10/02/2020

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
• Device Lot Number: NM0303
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 11/18/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1