MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRAY SZ4 LMRL; EARLY INTERVENTION : KNEE TIBIAL TRAY

Model Number 1024-51-400

Device Problems Loss of or Failure to Bond (1068); Malposition of Device (2616)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 09/16/2020

Event Type  Injury  

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 Description

Patient underwent primary lm unicompartmental knee replacement on (b)(6) 2019 where a sigma partial was utilised ((b)(6)).Patient has reported that the knee has never felt totally good.Patient has reported ongoing pain.X-rays indicate a possible loose tibial component with possible sub-optimal positioning at time of index surgery.A decision was made to revise the sigma partial to a total knee on (b)(6) 2020 ((b)(6) hospital).On opening the knee, the tibial tray was not well fixed.All components were removed and a stemmed tibial component (sleeve and stem) implanted on the tibial side and a primary attune ps femur on the femoral side.Patient status/ outcome / consequences: unknown, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? pain and possible tibial loosening, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study: no, (b)(4).Device property of: none, device in possession of: none, (b)(4).Device property of: none, device in possession of: none, (b)(4).Device property of: none, device in possession of: none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot : no deviations or non-conformance's were noted.

• Brand Name: SIGMA HP UNI TIB TRAY SZ4 LMRL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10601071
• MDR Text Key: 209120518
• Report Number: 1818910-2020-21122
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002345
• UDI-Public: 10603295002345
• Combination Product (y/n): N
• PMA/PMN Number: K070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

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
• Device Operator: Health Professional
• Device Model Number: 1024-51-400
• Device Catalogue Number: 102451400
• Device Lot Number: HC1716
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPETITOR - PALACOS.; SIGMA HP UNI FEMORAL SZ4 LM/RL.; SIGMA HP UNI INS SZ4 8MM LM/RL.
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR