MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG TIB CEM STM 13X60 2/2.5/3; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-6402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned devices revealed a tibial cemented stem was used off label in conjunction with the revised femoral construct.The investigation attributed the root cause of the reported event to user error.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.
Event or Problem Description
Intraoperatively during a planned knee surgery because of patella-upgrade the femoral component was found to be fractured.Doi: unknown, dor: (b)(6) 2021.Additionally a stem and sleeve component were reported as associated with the adverse event.

• Brand Name: SIG TIB CEM STM 13X60 2/2.5/3
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11750470
• Report Number: 1818910-2021-09250
• Device Sequence Number: 3091938
• Product Code: JWH
• UDI-Device Identifier: 10603295216902
• UDI-Public: 10603295216902
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K882234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 86-6402
• Device Catalogue Number: 866402
• Device Lot Number: D15030149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 110