MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 UNKNOWN OTHER PRODUCTS

Catalog Number UNK KNEE INSTRUMENT

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Not Applicable (3189)

Event Date 08/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during the assembly of the initial femoral replacement components, the complete femoral construct (femoral component, distal augments, posterior augments, sleeve and stem) slid off of the attune revision assembly base and fell onto the floor.Now contaminated, the initial femoral replacement components had to be replaced with a second set of components.After the surgeon assembled the femoral sleeve onto the femoral component, the rotation of the femoral sleeve shifted slightly as the universal stem was being screwed on and tightened to the femoral sleeve.Apparently, the morse taper did not seal completely during the impaction of the sleeve onto the femoral component, which was the prior step in the assembly process.Surgeon had struck the sleeve impactor once with a mallet, to seal the morse taper between the sleeve and femoral component, but the force of the impaction must not have been sufficient enough the seal the taper.Surgeon then attempted to remove the stem from the sleeve, so he could reposition the sleeve on the femoral component.As he was attempting to unscrew the stem from the sleeve, the attune wrench he was using slipped off of the stem abruptly, causing the complete femoral construct to slip off of the assembly base and onto the floor.Since only one set of attune revision implant components were available for this surgery, surgeon utilized alternate size attune revision femoral components to complete the surgery.To make the second set of components fit properly, additional resections, broaching, and trialing were required, which extended the surgery time approximately thirty minutes.Doi: unknown, doe: (b)(6) 2018.

Manufacturer Narrative

Pc-(b)(4).The device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN OTHER PRODUCTS
• Type of Device: OTHER PRODUCTS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7870409
• MDR Text Key: 120382255
• Report Number: 1818910-2018-69192
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE INSTRUMENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2018
• Initial Date FDA Received: 09/12/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 69 YR