MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XSM 12MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number	1987-27-112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	10/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgeon reported to bfarm: "sudden increase of pain in the left knee joint after a fall event.".
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).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: visual examination of the returned device found circular grooves/heavy wear on the poly component of the device.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 lot# cannot be seen due to the damage that the device presents.

• Brand Name: LPS UNIV TIB HIN INS XSM 12MM
• 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 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: 13558330
• Report Number: 1818910-2022-03069
• Device Sequence Number: 3868476
• Product Code: KRO
• UDI-Device Identifier: 10603295079392
• UDI-Public: 10603295079392
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/18/2022

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: 1987-27-112
• Device Catalogue Number: 198727112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Supplement Date Received by Manufacturer: 03/08/2022; 03/18/2022; 04/21/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 03/14/2022; 03/24/2022; 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 DISTAL FEM COMP XSM LT (EX PKT).; LPS UNIV TIB HIN INS XSM 12MM.; UNIV FEM SLEEVE CEM 20MM.; UNK KNEE FEMORAL ADAPTOR LPS.; UNK KNEE FEMORAL ADAPTOR LPS.; UNK KNEE FEMORAL AUGMENT LPS.; UNK KNEE FEMORAL AUGMENT LPS.; UNK KNEE FEMORAL LPS.; UNK KNEE LPS.; UNK KNEE LPS.; UNK KNEE STEM LPS.; UNK KNEE STEM LPS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female