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

Catalog Number 4540-0210

Device Problems Connection Problem (2900); 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 06/08/2015

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

(b)(6) at the clinic, reported the following event to (b)(4) : "incorrect adaptation between the tibial insert and metallic baseplate.Change for a polyethylene insert.No adverse consequences.".

Manufacturer Narrative

An event regarding seating/locking issues involving a unix uni knee tib bear insert was reported.The event was not confirmed.Method & results: -device evaluation and results: damage was noted on the underside of the tibial insert likely caused during attempted implantation.A dimensional inspection was performed and the device was confirmed to be the correct size.-medical records received and evaluation: no patient history was provided and no adverse consequences to the patient were reported.-device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.A review of the inspection guide sheet associated with the dhr did not indicate any evidence of a dimensional issue.100% inspection was carried out for all features for all units within the lot, all of which conformed to the required specifications.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined, the damage on the returned device however likely occured during attempted implantation.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.No further investigation is required at this time.If further relevant information becomes available this investigation will be re-opened.

Event Description

Pharmacist at the clinic, reported the following event to (b)(6) ca ansm: "incorrect adaptation between the tibial insert and metallic baseplate.Change for a polyethylene insert.No adverse consequences.".

• 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 NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4921936
• MDR Text Key: 22473413
• Report Number: 0002249697-2015-02375
• 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: 06/24/2015

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 Expiration Date: 01/31/2016
• Device Catalogue Number: 4540-0210
• Device Lot Number: CPPKD04A
• Other Device ID Number: STERILE LOT# 11010P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2011
• 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