MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R FEM LT SZ 4 TRL; KNEE INSTRUMENT : FEMORAL TRIALS

Model Number	96-1004
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that surgeon was a long time loyal user of the depuy cement-less cruciate retaining, sigma femoral component.On friday, (b)(4) the surgeon made the normal cuts and used the standard metal size 4 c/r femoral trial.Everything fit normal.The real implants were opened and implantation was initiated.The size 4 left cement-less sigma femoral component failed to seat distally.The surgeon noticed a gap no less than 3mm on the distal lateral aspect of the femur between the impact and the bone.The femur was otherwise fully seated.The femur was then removed and a cemented implant opened.They were sending the 4 in 1 cutting block, the femoral trial and the actual femoral impact for review.
Event or Problem Description
Additional information received stated that the femoral trial had been used previously on numerous occasions, however, the femoral trial first well on the cut surfaces.There was a 20-minute surgical delay.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.
Additional Manufacturer Narrative
Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Common Device Name: KNEE INSTRUMENT : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9856232
• Report Number: 1818910-2020-08666
• Device Sequence Number: 2921536
• Product Code: JWH
• UDI-Device Identifier: 10603295234586
• UDI-Public: 10603295234586
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 96-1004
• Device Catalogue Number: 961004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2020
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 03/12/2020; 03/26/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 03/25/2020; 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR