MAUDE Adverse Event Report: 1219655 DEPUY-RAYNHAM PRSVN ALLPOLY TIB RMLL S3 7MM; KNEE TIBIAL BEARING/INSERT

Catalog Number 149811306

Device Problems Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Naturally Worn (2988)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 02/12/2014

Event Type  Injury  

Event Description

Clinical report states poly wear and tibial loosening at the cement/bone interface.Depuy cement was used.Der from sales field was also received stating tibial loosening at the cement/implant interface.

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

(b)(4).The device associated with this report was not returned.Requests for additional investigational inputs were made in accordance with wi-7915 appendix a.Patient medical records and x-rays were provided.Review of the supplied investigational inputs confirmed the tibial component was loose and subsided.The root cause of the device loosening and migration is unknown.With the limited amount of information provided, it cannot be determined that the complaint is product related.Based on the inability to identify 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.

Manufacturer Narrative

Additional 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.

• Brand Name: PRSVN ALLPOLY TIB RMLL S3 7MM
• 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: 4117074
• MDR Text Key: 4936810
• Report Number: 1818910-2014-28757
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK010810
• 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: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2008
• Device Catalogue Number: 149811306
• Device Lot Number: X2HBC4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2003
• 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: 61 YR
• Patient Weight: 100