MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRAY SZ2 RMLL; EARLY INTERVENTION : KNEE TIBIAL TRAY

Model Number	1024-52-200
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Discomfort (2330)
Date of Event	06/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Removal due to sore prosthesis and partial mobilization of the tibial component.Reason the device was used: right knee medial compartment prosthetic replacement for medial primary osteoarthritis.Doi: (b)(6) 2020.Dor: (b)(6) 2022; right knee.
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.
Additional Manufacturer Narrative
Product complaint # = > pc-001158912 investigation summary = > no device associated with this report was received for examination.Review of the photographic evidence cannot confirm the complaint.Based on the provided evidence, it cannot be determine a progressive decay of implant position in relation to initial implantation position.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot = > the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SIGMA HP UNI TIB TRAY SZ2 RMLL
• Common Device Name: EARLY INTERVENTION : KNEE TIBIAL TRAY
• 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: 15112907
• Report Number: 1818910-2022-14213
• Device Sequence Number: 17604748
• Product Code: HRY
• UDI-Device Identifier: 10603295002383
• UDI-Public: 10603295002383
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K070267
• 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
• Report Date (Section B): 07/27/2022

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: 1024-52-200
• Device Catalogue Number: 102452200
• Device Lot Number: J55G13
• 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: 07/11/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• 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: SIGMA HP UNI FEMORAL SZ2 RM/LL.; SIGMA HP UNI INS SZ2 7MM RM/LL.; SIGMA HP UNI TIB TRAY SZ2 RMLL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Unknown