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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/26/2021

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 was revised for pain.Surgeon revised patient to a total knee replacement.All uni implants were extracted.There was no loosening of the uni implants.Once all implants were extracted, proceeded with total knee replacement.Implanted a crs femur and attune rp revision tray with a 5mm rp stabilize insert.There was no delay in surgery.There was no injury to the patient.This was the patient's left knee.Original date of surgery was (b)(6) 2015.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 : 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.

Event Description

Additional information received stated that this was due to natural progression and an acl tear.Cement used was depuy ghv.

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 synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

• 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: 11761143
• MDR Text Key: 248550729
• Report Number: 1818910-2021-09410
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 1024-51-400
• Device Catalogue Number: 102451400
• Device Lot Number: 574396
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 04/22/2021; 06/14/2021
• Supplement Dates FDA Received: 05/11/2021; 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIGMA HP UNI FEMORAL SZ3 LM/RL; SIGMA HP UNI INS SZ4 8MM LM/RL; SMARTSET GHV GENTAMICIN 40G; SIGMA HP UNI FEMORAL SZ3 LM/RL; SIGMA HP UNI INS SZ4 8MM LM/RL
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 106