MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ2 8MM LM/RL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number 1024-53-208

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2021

Event Type  malfunction  

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

Could not lock the insert.It was reported that during the surgery of single condylar replacement, the insert could not match with plateau(as the video shows).Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

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.

Event Description

Additional information received indicated that there was no surgical delay because of this event.

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.H10 additional narrative: added: d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : the device associated with this report was returned for analysis.Examination of the returned device found some scratches and marks possibly related to manipulation during surgery.Since the tibial component was not returned, a functional test was not possible, therefore the reported complaint was not confirmed.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 : a manufacturing record evaluation was performed for the finished device [jc0248] number, and no non-conformances were identified.

• Brand Name: SIGMA HP UNI INS SZ2 8MM LM/RL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL INSERT
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12689341
• MDR Text Key: 278133648
• Report Number: 1818910-2021-23428
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002499
• UDI-Public: 10603295002499
• 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,Followup,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1024-53-208
• Device Catalogue Number: 102453208
• Device Lot Number: JC0248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1