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

Model Number	1987-27-312
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2023
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 of a universal lps inlay because of inlay fracture into several pieces.Doi: (b)(6) 2022.Doe: (b)(6) 2023.Affected side: unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : revision of a universal lps inlay because of inlay fracture into several pieces.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned sample revealed that the lps univ tib hin ins med 12mm was found broken in 2 parts since the cylindric part.Also this condition affected the polyethylene piece where it was broken in two parts.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the lps univ tib hin ins med 12m would contribute to the complained device issue.Based on the investigation findings, the potential cause cannot be established.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : 1) quantity manufactured: (b)(4), 2) date of manufacture: 6/4/2022, 3) any anomalies or deviations identified in dhr: no anomalies or non conformances were identified.4) expiry date: 5/31/2027, 5) ifu reference: 090200773.
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: 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: 1) quantity manufactured: 8.2) date of manufacture: 6/4/2022.3) any anomalies or deviations identified in dhr: no anomalies or non conformances were identified.4) expiry date: 5/31/2027.5) ifu reference: 090200773.

• Brand Name: LPS UNIV TIB HIN INS MED 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: 17371371
• Report Number: 1818910-2023-14911
• Device Sequence Number: 3827020
• Product Code: KRO
• UDI-Device Identifier: 10603295079576
• UDI-Public: 10603295079576
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 07/21/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1987-27-312
• Device Catalogue Number: 198727312
• Device Lot Number: M0053Z
• 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: 07/07/2023
• Supplement Date Received by Manufacturer: 08/13/2023; 09/19/2023; 09/26/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 08/14/2023; 09/20/2023; 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2022
• 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: COMPETITOR CEMENT; LPS UNIV TIB HIN INS MED 12MM; MBT REVISION CEM TIB TRAY SZ 3; MBT TRAY SLEEVE POR M/L 53MM; SROM NRHFEM W/PIN MEDLFT 71X66; SROM*NRH REPL HINGE PIN/MEDIUM; UNIVERSAL FEM SLV DIS POR 46MM; UNIVERSAL STEM 115X18MM FLUTED; UNIVERSAL STEM 75X20MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male