MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS PROX TIB REPLC COMP XSM; LPS AND S-ROM : KNEE TIBIAL TRAY

Model Number	1987-21-105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This report filled after the review of a clinical evaluation report (cer) from a related research activity database (drra) for patients implanted with depuy syn.(46) hip cohort- involving proximal femoral body implant.(72) knee cohort- involving distal femur implant.(13) total- involving both proximal and distal implants.(72) none- not requiring the proximal or distal implant.Complications sustained within 5 year review: 53 patients sustained a subsequent surgery after the primary implantation of lps products.76 patients had an infection after the primary implantation of lps products.75 patients had a mechanical complication after the primary implantation of lps products.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.

• Brand Name: LPS PROX TIB REPLC COMP XSM
• Common Device Name: LPS AND S-ROM : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14083790
• Report Number: 1818910-2022-06569
• Device Sequence Number: 20152632
• Product Code: KRO
• UDI-Device Identifier: 10603295079071
• UDI-Public: 10603295079071
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K062301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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: 1987-21-105
• Device Catalogue Number: 198721105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown