MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL FEM SLV DIS POR 46MM; LPS AND S-ROM : KNEE FEMORAL

Model Number	1987-14-105
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/23/2022
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
Knee prosthesis which had been placed on (b)(6) 2022.August 2022: secondary prosthetic displacement with rotational disorder -> external hyper-rotation of the lower limb secondary to a prosthetic rotational disorder occurring at the lps prosthetic metaphysis/sleeve junction cemented in the femur.Hyper external rotation of the right lower limb during flexion risk of micromobility of a metal-metal couple return to the operating room arthrotomy for replacement of the defective part.
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.H10 additional narrative:  added: d9, d10 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
Additional information received indicated that there was no movement between the implant and the bone.There was a rotation between femoral implant and the sleeve requiring revision surgery.
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.H10 additional narrative:  added: b5.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d10 (concomitant products).
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.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 device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the required lot code was not provided.
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
Additional information received indicated that based on the event description and specifically highlighted area, the recorded ips are accurate.The sleeve junction is made up of the sleeve adapter (lps fem to sleeve adapter +5) and the femoral sleeve (universal fem slv dis por 46mm).The fem sleeve does not come in direct contact with the lps distal fem comp xsm rt, additionally, the femoral component did not present any damage or issue in the assembly feature.

• Brand Name: UNIVERSAL FEM SLV DIS POR 46MM
• Common Device Name: LPS AND S-ROM : KNEE FEMORAL
• 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: 15410771
• Report Number: 1818910-2022-17784
• Device Sequence Number: 6999436
• Product Code: JWH
• UDI-Device Identifier: 10603295026358
• UDI-Public: 10603295026358
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 09/13/2022

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: 1987-14-105
• Device Catalogue Number: 129453245
• Device Lot Number: J41D28
• 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: 08/25/2022
• Supplement Date Received by Manufacturer: 09/27/2022; 09/27/2022; 11/17/2022; 06/16/2023
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 10/12/2022; 10/12/2022; 11/21/2022; 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2019
• 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: CIMENT ORTHOPED COPAL GENTA+VANCO; LPS DISTAL FEM COMP XSM RT; LPS FEM TO SLEEVE ADAPTER +5; LPS UNIV TIB HIN INS XSM 14MM; MBT REVISION CEM TIB TRAY SZ 3; MBT TRAY SLEEVE POR M/L 53MM; OBT DIAPHYS 38MM PLUG; OBT DIAPHYS 38MM PLUG; P.F.C.* FLUT TIB ROD 150X12MM; P.F.C.* TIB STM EXT 4/5/6 60MM; PFC*SIGMA/OV/DOME PAT 3PEG,41; PG ADAPTOR FEMOR LPS +5; SROM*NRH REPL HINGE PIN/XSM/SM; UNIVERSAL FEM SLV DIS POR 46MM; UNK KNEE FEMORAL ADAPTOR LPS; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown