MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ABGII HOODED INS. 5628; IMPLANT

Catalog Number 4845-2-856

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

A distributor from (b)(6), reported the following event (for the (b)(6) hospital) : "abgii insert impossible to fix inside the cup.".

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.

Manufacturer Narrative

An event regarding size/fit issue with an agb liner was reported.The event was not confirmed.Method and results: device evaluation and results: visual inspection confirmed that the abgii insert was damaged during use.It was noted that one side of the device is more damaged, which could be a result of the insert being introduced in the cup in an inclined way.There was also evidence of damage to the holes which could indicate that the instrument may not have been correctly introduced on the insert.Dimensional inspection: visual inspection confirmed that the abgii insert was damaged during use.Therefore it was not possible to perform a full dimensional inspection.However some dimensions were measured in the areas not too damaged and confirmed that it is the correct size.Medical records received and evaluation: not performed as medical records were not received for evaluation.Device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies complaint history review: a review of the complaint history database shows that there have been no similar reported events for the subject lot code.Conclusions: the exact cause of this event could not be determined based on the information available.The returned device was returned and confirmed that is was the correct size.

Event Description

A distributor from (b)(4), reported the following event (for the (b)(6) hospital) : "abgii insert impossible to fix inside the cup.".

• Brand Name: ABGII HOODED INS. 5628
• 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: 4343365
• MDR Text Key: 21720622
• Report Number: 0002249697-2014-04765
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4845-2-856
• Device Lot Number: G3916942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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