MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS CEMENTED STEM 10X100MM STR; LPS AND S-ROM : KNEE STEMS

Model Number	1987-25-110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/19/2022
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 of a right lps femoral replacement and stem.Patient had fracture the femoral stem component of the lps.No fall reported by the patient, he claims he just felt the knee become loose or wobbly.No infection present at the time of the procedure.Standard specimens for a revision taken.Primary surgery done on (b)(6) 2020.
Event or Problem Description
Additional information received: a.Was the bone cement/s used depuy manufactured? if yes, please provide the quantity, product and lot numbers.Not known, however no depuy cement listed in patient's primary usage from kit diary.B.Was surgery time extended? if yes, what is the duration of the delay? no delay reported.
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 : a manufacturing record evaluation (nc search) was performed for the finished device (b)(4) lot j0334z and no non-conformances / manufacturing irregularities were identified.
Event or Problem Description
Affected side: right knee.
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 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.

• Brand Name: LPS CEMENTED STEM 10X100MM STR
• Common Device Name: LPS AND S-ROM : KNEE STEMS
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15529965
• Report Number: 1818910-2022-19374
• Device Sequence Number: 12269245
• Product Code: JWH
• UDI-Device Identifier: 10603295079149
• UDI-Public: 10603295079149
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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,Followup
• Report Date (Section B): 10/03/2022

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: 1987-25-110
• Device Catalogue Number: 198725110
• Device Lot Number: J0334Z
• 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: 09/18/2022
• Supplement Date Received by Manufacturer: 10/14/2022; 12/13/2022; 02/07/2023
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 10/24/2022; 12/14/2022; 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• 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: CTM LPS DIST FEMUR XS LP RIGHT; LPS CEMENTED STEM 10X100MM STR; LPS DISTAL FEM COMP XSM RT; LPS SEGMENTAL COMPONENT 25MM; LPS SEGMENTAL COMPONENT 25MM; LPS UNIV TIB HIN INS XSM 12MM; MBT REVISION CEM TIB TRAY SZ 2; MBT TRAY SLEEVE POR M/L 29MM; UNIVERSAL STEM 115X12MM FLUTE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male