MAUDE Adverse Event Report: DEPUY IRELAND-REG. # 9616671 SIGMA HP UNI INS SZ2 7MM LM/RL; KNEE TIBIAL BEARING/INSERT

Catalog Number 102453207

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 12/10/2015

Event Type  malfunction  

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.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Surgeon had difficulty seating the insert.A second insert was opened and seated on the first attempt.

Manufacturer Narrative

Examination of the returned device confirmed damage consistent with an unsuccessful attempt to mate the tibial insert and tray.A worldwide complaint database search found no other reported incidents against the provided product/lot combination 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 investigation could not draw any conclusions regarding the reported event with the information provided.Based on the inability to determine a root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should 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 IRELAND-REG. # 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND-REG. # 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5316167
• MDR Text Key: 34045051
• Report Number: 1818910-2015-37996
• 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
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 102453207
• Device Lot Number: 669082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2015
• 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
• Patient Age: 64 YR