MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE FEMORAL SIGMA; FEMORAL

Catalog Number UNK KNEE FEMORAL SIGMA

Device Problems Loss of or Failure to Bond (1068); Off-Label Use (1494)

Patient Problem Insufficient Information (4580)

Event Date 03/20/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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.

Event Description

The patient was scheduled to have a revision procedure to remove a worn poly insert and implant a new poly insert.The original poly insert was removed and the surgeon trailed a size 5x10mm and stated that it felt good.He wanted to try a 5x12.5mm, so he trialed that size and stated that it was a better fit.He asked what the next size was and was told it was a 5x15mm.The surgeon said he wanted to see if he could make "more room" and try the 5x15mm poly insert.He proceeded with a cobb and mallet to try and create more space for the 5x15 poly insert.While doing this, the surgeon hit the femoral implant and it became loose.He stopped to investigate the loosening for the femoral implant.It was indeed loose on the medial side.Being that the only implants available were poly inserts, he decided to implant the new poly and close the patient.The case was extended approximately 30 minutes due to this event.He stated he was going to brace the patient's leg and transport him to (b)(6) medical center to have a total knee revision done on the patient.There was loosening of the femoral implant at the cement/implant interface and the cement manufacturer was unknown.Doi: unknown dor: (b)(6) 2023 affected side: right knee.

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 (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK KNEE FEMORAL SIGMA
• Type of Device: FEMORAL
• 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: 16680870
• MDR Text Key: 312676297
• Report Number: 1818910-2023-07329
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

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 Catalogue Number: UNK KNEE FEMORAL SIGMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 04/25/2023
• Supplement Dates FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 FEMORAL SIGMA; UNK KNEE TIBIAL INSERT SIGMA; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male