MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ4 8MM LM/RL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number	1024-53-408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/26/2021
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
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.Additional information received stated that this was due to natural progression and an acl tear.
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 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.

• Brand Name: SIGMA HP UNI INS SZ4 8MM LM/RL
• Common Device Name: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11840902
• Report Number: 1818910-2021-10524
• Device Sequence Number: 14238478
• Product Code: HRY
• UDI-Device Identifier: 10603295002598
• UDI-Public: 10603295002598
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K070267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 1024-53-408
• Device Catalogue Number: 102453408
• Device Lot Number: 330154
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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: SIGMA HP UNI FEMORAL SZ3 LM/RL; SIGMA HP UNI TIB TRAY SZ4 LMRL; SMARTSET GHV GENTAMICIN 40G; SIGMA HP UNI FEMORAL SZ3 LM/RL; SIGMA HP UNI TIB TRAY SZ4 LMRL; SMARTSET GHV GENTAMICIN 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 106