MAUDE Adverse Event Report: DEPUY INTL., LTD. ¿ REG. # 8010379 PRSVN MB INSERT SZ4 9.5MM; KNEE TIBIAL BEARING/INSERT

Catalog Number 149815408

Device Problem Naturally Worn (2988)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 06/16/2016

Event Type  Injury  

Manufacturer Narrative

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

Patient required a revision on their uni knee to a total knee replacement due to wear of the poly on the mobile bearing insert resulting in pain and discomfort.

Manufacturer Narrative

Conclusion and justification status: the complaint states patient required a revision on their uni knee to a total knee replacement due to wear of the poly on the mobile bearing insert resulting in pain and discomfort.Primary implant date: (b)(6) 2003.No issues occurred to the patient during the procedure.No further information is available.A complaints database search and review of manufacturing records did not identify any anomalies.No device associated with this report was received for examination.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.Without further information the root cause of the complaint cannot be determined.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per sep 419.Depuy still 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: PRSVN MB INSERT SZ4 9.5MM
• Type of Device: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY INTL., LTD. ¿ REG. # 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY INTL., LTD. ¿ REG. # 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 5772411
• MDR Text Key: 48857653
• Report Number: 1818910-2016-22657
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2011
• Device Catalogue Number: 149815408
• Device Lot Number: XYV21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2001
• 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: 77 YR