MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 21MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number	1987-27-121
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fall (1848); Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Periprosthetic fracture.Doi: (b)(6) 2021; dor: (b)(6) 2021; right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.All available x-rays were reviewed, and no evidence of implant fracture or anything indicative of a device nonconformance was found.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.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: LPS UNIV TIB HIN INS XSM 21MM
• Common Device Name: LPS AND S-ROM : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13632821
• Report Number: 1818910-2022-03787
• Device Sequence Number: 20134104
• Product Code: KRO
• UDI-Device Identifier: 10603295079439
• UDI-Public: 10603295079439
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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: 1987-27-121
• Device Catalogue Number: 198727121
• Device Lot Number: J7738H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LPS CEMENTED STEM 14X125MM STR; LPS DISTAL FEM COMP XSM RT; LPS SEGMENTAL COMPONENT 25MM; LPS UNIV TIB HIN INS XSM 21MM; MBT REV TIB TRAY SIZE 4 15MM; MBT TRAY SLEEVE CEM M/L 29MM; S&N RESTRICTOR CEMENT BUCK FLANGE; S&N RESTRICTOR CEMENT BUCK FLANGE; SIG TIB CEM STM 13X60 2/2.5/3; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001; STRYKER CEMENT 61971001
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Unknown
• Patient Weight: 107 KG