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

Model Number	1024-51-200
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Revision of a depuy sigma uni knee replacement.Reason for revision was due to medial collapse/loosening of implants.All implants were removed and an attune total knee was implanted.Implants not available for return.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.
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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: 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 was received stated that the tibial component was loose and had subsided.Cmw2 would have been used.There was no any adverse consequences that affected the patient because of implant migration and we were able to implant a primary knee replacement as there wasn¿t any significant bone loss.

• Brand Name: SIGMA HP UNI TIB TRAY SZ2 LMRL
• Common Device Name: EARLY INTERVENTION : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11711684
• Report Number: 1818910-2021-08478
• Device Sequence Number: 3309620
• Product Code: HRY
• UDI-Device Identifier: 10603295002321
• UDI-Public: 10603295002321
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K070267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2021

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: 1024-51-200
• Device Catalogue Number: 102451200
• Device Lot Number: J2694H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 04/26/2021; 06/29/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 05/13/2021; 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CMW2; SIGMA HP UNI FEMORAL SZ2 LM/RL; SIGMA HP UNI INS SZ2 7MM LM/RL
• Outcome Attributed to Adverse Event: Required Intervention