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

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Loss of Range of Motion (2032); Discomfort (2330)

Event Date 06/17/2022

Event Type  Injury  

Event 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.

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.

Manufacturer Narrative

Product complaint #
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> pc-001158912 investigation summary
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> 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
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> 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
• Type of Device: 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
• MDR Text Key: 296682745
• Report Number: 1818910-2022-14213
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002383
• UDI-Public: 10603295002383
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SIGMA HP UNI FEMORAL SZ2 RM/LL.; SIGMA HP UNI INS SZ2 7MM RM/LL.; SIGMA HP UNI TIB TRAY SZ2 RMLL.
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR