MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRAY SZ3 LMRL; EARLY INTERVENTION : KNEE TIBIAL TRAY

Catalog Number 102451300

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

Patient Problems Ossification (1428); Unspecified Musculoskeletal problem (4535)

Event Date 10/21/2021

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

Revision of a sigma uni tkr.Reason for revision was due to impingement due to excess bone on the medial side of the tibial plateau.No issue with the implants themselves.The poly was removed in order to obtain access so the bone could be cleared.A new poly of the same thickness was then implanted.

Event Description

Additional information received indicated that there was no surgical delay.The affected side was the left side.

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.Udi : (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays were reviewed, and there is no evidence that the complaint is product related 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 SZ3 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 RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12751618
• MDR Text Key: 280117547
• Report Number: 1818910-2021-24396
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 102451300
• Device Lot Number: 515022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2014
• 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 FEMORAL SZ3 LM/RL; SIGMA HP UNI INS SZ3 7MM LM/RL; SIGMA HP UNI INS SZ3 7MM LM/RL; UNK KNEE TIBIAL TRAY UNI; SIGMA HP UNI INS SZ3 7MM LM/RL; UNK KNEE TIBIAL TRAY UNI
• Patient Outcome(s): Required Intervention