MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRAY SZ1 LMRL; EARLY INTERVENTION : KNEE TIBIAL TRAY

Model Number 1024-51-100

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

Patient Problem Bone Fracture(s) (1870)

Event Date 03/11/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Tibial plateau fracture intro-op.It was reported that patient underwent a medial plateau tibial fracture when the tibial was assembled during the left medial compartmental arthroplasty.Then surgeon implanted two screws to support the fixation.The patient has not yet recovered.Doe: (b)(6) 2022.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.Available xray evidence was reviewed.Based in attached photographic evidence, it cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.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 TIB TRAY SZ1 LMRL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL TRAY
• 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: 14186317
• MDR Text Key: 289862003
• Report Number: 1818910-2022-07281
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002314
• UDI-Public: 10603295002314
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1024-51-100
• Device Catalogue Number: 102451100
• Device Lot Number: J7947X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2020
• 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: SIGMA HP UNI INS SZ1 8MM LM/RL
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 50 KG