MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNIX UNI KNEE TIB BEAR INSERT; IMPLANT

Catalog Number 4540-0208

Device Problems Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Event Description

Impossible for the surgeon to clip the insert at the end of the surgery (even after "reaming" the polyethylene).Another insert (same reference, different lot number) was used.

Manufacturer Narrative

An event regarding a seating/locking issue involving a unix insert was reported.The event was not confirmed.Method & results: device evaluation and results: there was damage noted on the underside of the insert as result of attempts to ream the device during surgery.A dimensional inspection was performed and the device was confirmed to be the correct size.Two dimensions could not be measured during the damage caused during implantation attempts.Medical records received and evaluation: there were no medical records provided for review.Device history review: the device was manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined based on the information provided.A review of the dhr indicated that 100% inspection was carried out for all features for all units within the lot, all of which conformed to the required specifications prior to shipment from stryker orthopaedics.The returned device was confirmed to be the correct size, although 2 dimension could not be measured due to the damage caused during implantation attempts.No further investigation is possible at this time.If further relevant information becomes available this investigation will be re-opened.

Event Description

Impossible for the surgeon to clip the insert at the end of the surgery (even after "reaming" the polyethylene).Another insert (same reference, different lot number) was used.

• Brand Name: UNIX UNI KNEE TIB BEAR INSERT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill 00000
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5147298
• MDR Text Key: 28505406
• Report Number: 0002249697-2015-03371
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K923011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Pharmacist
• Type of Report: Followup
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 4540-0208
• Device Lot Number: CPPRH01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2015
• 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): Other