MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SIGMA HP UNI INS SZ2 7MM LM/RL; KNEE TIBIAL BEARING/INSERT

Catalog Number 102453207

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6) 2016 (b)(4), (b)(6) 2020.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

The poly insert would not lock into the tray.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The received device was forwarded to commercialized product development for evaluation.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Review of the device history records did not reveal any related manufacturing deviations or anomalies on the provided product and lot combination.The damage is consistent with unsuccessful attempts to mate the tibial insert and tray.The root cause, however, cannot be definitively determined with the information provided.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: SIGMA HP UNI INS SZ2 7MM LM/RL
• Type of Device: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5408254
• MDR Text Key: 37728586
• Report Number: 1818910-2016-12622
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 102453207
• Device Lot Number: 722692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2016
• 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