MAUDE Adverse Event Report: DEPUY IRELAND ¿ REG. # 9616671 MBT CEM KEEL TIB TRAY SZ3; KNEE TIBIAL TRAY

Catalog Number 129433130

Device Problem Malposition of Device (2616)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Swelling (2091)

Event Date 04/10/2017

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

Revision surgery was performed on (b)(6) 2017 (b)(6) hospital due to patients complaint of pain and swelling.Surgeon reports he can see from the x-ray he has implanted the tray in varus.During surgery surgeon reports minimal metallosis and minimal poly wear.

Manufacturer Narrative

Conclusion and justification status: the complaint states revision surgery was performed on (b)(6) 2017 grace hospital due to patients complain of pain and swelling.Surgeon reports he can see from the x-ray he has implanted the tray in varus.During surgery, surgeon reports minimal metallosis and minimal poly wear.He also reports the patient may have a low grade chronic infection.He reports no fault of the implant itself.All primary implant removed and pfc ps femur, mbt revision tray with 30mm cemented stem attached, and 15mm poly insert implanted.A complaint database search and review of manufacturing records did not identify any anomalies.The devices were reviewed by bioengineering and a report was received stating; following visual inspection, there are no signs of manufacturing or device defect.The insert appears to be worn where the lateral femoral condyle contacts the insert, which is apparent through discoloration and texture.As there is no further information available it is not possible to determine the cause of this.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MBT CEM KEEL TIB TRAY SZ3
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND ¿ REG. # 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY IRELAND ¿ REG. # 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6551076
• MDR Text Key: 74601698
• Report Number: 1818910-2017-17722
• Device Sequence Number: 1
• Product Code: NJL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• 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: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 129433130
• Device Lot Number: 2580924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2008
• 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