MAUDE Adverse Event Report: 1219655 DEPUY-RAYNHAM SIGMA HP UNI INS SZ3 7MM RM/LL; KNEE TIBIAL BEARING/INSERT

Catalog Number 102454307

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 12/08/2014

Event Type  Injury  

Event Description

Patient was revised to address pain.

Event Description

Update rec¿d 01/05/2015 - patient's medical records were received.Records were reviewed for mdr reportability.According to the medical records the patient was revised to address instability as well.There is no new information that would change the existing mdr decision.

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.(b)(4).

Manufacturer Narrative

(b)(4).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

(b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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 SZ3 7MM RM/LL
• Type of Device: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): 1219655 DEPUY-RAYNHAM; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): 1219655 DEPUY-RAYNHAM; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4371935
• MDR Text Key: 5290099
• Report Number: 1818910-2014-35436
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 102454307
• Device Lot Number: 127480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2015
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/02/2015; 02/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2011
• 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 Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 76