MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ5 7MM RM/LL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Catalog Number 102454507

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

"voluntary report received (mw5119018) and product: depuy sigma uka partial knee bearing (medical device failed twice).On 6/13/23, complaint received from (b)(6), excerpted: "complainant stated the surgeries occurred at (b)(6) orthopedic surgery, (b)(6) which dr.(b)(6) operated.Complainant reported he had one partial knee surgery and a second one that was an emergency revision of the first surgery.Complainant stated one of the knee reconstructions failed in (b)(6) 2020 while he was climbing stairs at a state wrestling tournament.Complainant stated the polyurethane came out of place.Complainant stated he has a partial knee replacement conducted to save the knee replacement.When the knee replacement failed a second time, his doctor recommended he obtain a second opinion or obtain another second full knee replacement.Complainant stated he obtained a second opinion from dr.(b)(6).Dr.(b)(6) informed him that he would not perform a knee replacement surgery after another doctor had previously conducted surgery the first time.Dr.(b)(6) informed the complainant he would perform the full knee replacement surgery with the assistance by dr.(b)(6)." the complainant stated one of the knee reconstructions failed in (b)(6) 2020 while he was climbing stairs at a state wrestling tournament.Complainant stated the polyurethane came out of place.The patient is status-post-right partial knee replacement revision performed on (b)(6) 2019 and a right partial knee replacement performed on (b)(6) 2018.Reference report: mw5119019." doi- unknown.Dor- unknown.Affected side- right knee.

Manufacturer Narrative

Product complaint (b)(4).E3: the initial reporter has been removed for confidentiality/privacy.The initial reporter is the patient.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 # (b)(4).Investigation summary: no device associated with this report was received for examination.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.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 manufacturing record evaluation was performed for the finished device 102454507, lot j03c87 and no non-conformances / manufacturing irregularities were identified.

• Brand Name: SIGMA HP UNI INS SZ5 7MM RM/LL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL INSERT
• 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: 17390527
• MDR Text Key: 319842243
• Report Number: 1818910-2023-15124
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 10603295002932
• UDI-Public: 10603295002932
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102454507
• Device Lot Number: J03C87
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2018
• 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: UNK KNEE TIBIAL TRAY UNI.
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male