MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB XLK INS 2.5 15MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-22-115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Loss of Range of Motion (2032)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
Right knee joint replacement required revision due to inability for the patient to flex his knee, of note the femur had been previously revised and was a stemmed tc3 revision femur, the tibial component was still the primary tibial mbt component originally implanted previously.Reason for previous primary and revision is unknown.Unable to gain the reference numbers from other implants as the relevant areas were covered by cement or unreadable.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.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.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: SIGMA STAB XLK INS 2.5 15MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11648706
• Report Number: 1818910-2021-07642
• Device Sequence Number: 3397585
• Product Code: JWH
• UDI-Device Identifier: 10603295064190
• UDI-Public: 10603295064190
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 03/25/2021

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: 1581-22-115
• Device Catalogue Number: 158122115
• Device Lot Number: 3241965
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MBT CEM KEEL TIB TRAY SZ4; SIGMA STAB XLK INS 2.5 15MM; UNK KNEE FEMORAL SIGMA; UNK KNEE STEM SIGMA; MBT CEM KEEL TIB TRAY SZ4; SIGMA STAB XLK INS 2.5 15MM; UNK KNEE FEMORAL SIGMA; UNK KNEE STEM SIGMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 109