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

Model Number	1987-27-012
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Dislocation of lps universal knee bearing.Bearing (insert / articulating surface) breakage and dislocation.The bearing breakage dislodged the metal reinforcement post the cone of the bearing / tibial insert.Bearing changed.Original surgeon dr (b)(6).The lps procedure was a revision of a periprosthetic fracture of a femur associated with a femoral component of a total knee replacement (not depuy synthes product).
Additional Manufacturer Narrative
(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.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 : a manufacturing record evaluation (nc search) was performed for the finished device 198727012, lot jd8600, and no non-conformances / manufacturing irregularities were identified.
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.
Event or Problem Description
This complaint only captures the fracture of the polyethylene.The dislocation and separation of the metal component from the poly component are all secondary to the fracture.Insert only implant revised yes obviously there was an adverse result for the patient as they had a revision and required intervention to cope with the dislocated bearing.There are no x-rays available as the patient has not consented to the sharing of any information.The bearing was discarded.

• Brand Name: LPS UNIV TIB HIN INS XXSM 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: 14103594
• Report Number: 1818910-2022-06705
• Device Sequence Number: 12369257
• Product Code: KRO
• UDI-Device Identifier: 10603295079330
• UDI-Public: 10603295079330
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 04/13/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1987-27-012
• Device Catalogue Number: 198727012
• Device Lot Number: JD8600
• 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: 03/29/2022
• Supplement Date Received by Manufacturer: 04/27/2022; 05/10/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 05/05/2022; 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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: ATTUNE MEDIAL DOME PAT 35MM.; CEMENTED LPS STEM (FEMUR).; LPS CEMENTED STEM 10X100MM STR.; LPS DISTAL FEM COMP XXSM LT.; LPS DISTAL FEM COMP XXSM LT.; LPS SEGMENTAL COMPONENT 35MM.; LPS SEGMENTAL COMPONENT 35MM.; LPS UNIV TIB HIN INS XXSM 12MM.; MBT REVISION CEM TIB TRAY SZ 2.; MBT REVISION CEM TIB TRAY SZ 2.; MBT TIBIAL METAPHYSEAL SLEEVE.; MBT TRAY SLEEVE POR M/L 29MM.; UNIVERSAL STEM 75X12MM FLUTED.; UNIVERSAL STEM 75X12MM FLUTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female