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	Pain (1994); Discomfort (2330)
Date of Event	09/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Revision completed due to pain and discomfort in her knee.The knee was revised where the srom hinge femoral component, the universal femoral sleeve, femoral universal stem and the lps insert were explanted.The mbt revision tray, mbt sleeve, and universal stem were left in situ on the tibial side.A lps distal femoral replacement and lls cemented stem were implanted.There was no surgical delay.Doi: unk.Dor: (b)(6) 2022.Affected side: left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the lot number: bfi161b does not reflect a valid finished goods lot number.Therefore, a manufacturing records evaluation (mre) was not performed as no valid finished goods lot number was provided for this device.

• 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15542777
• Report Number: 1818910-2022-19588
• Device Sequence Number: 14889703
• Product Code: KRO
• UDI-Device Identifier: 10603295079439
• UDI-Public: 10603295079439
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: BFI161B
• 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: 09/20/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 10/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK KNEE FEMORAL SROM; UNK KNEE UNIVERSAL STEM; UNKNOWN KNEE FEMORAL SLEEVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female