MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 22.2MM STD V40 HEAD; IMPLANT

Catalog Number 6260-4-122

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 01/02/2015

Event Type  Injury  

Event Description

It was reported that bipolar cup was implanted in (b)(6) 2014.On (b)(6) , bipolar cup separated from the inner head when the patient woke up.Revision surgery was performed on (b)(6).

Manufacturer Narrative

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

Manufacturer Narrative

The patient is (b)(6) in height.An event regarding disassociation involving a 22.2mm std v40 head was reported.The event was not confirmed.Method and results: device evaluation and results: a visual evaluation revealed that the 22.2mm std v40 head and system one bipolar head were returned assembled together as they would have been in vivo during implantation.The inner v40 head was securely locked in place and could not be disassembled from the bipolar head without the aid of a disassembly tool to release the plastic retaining ring.Upon disassembly both components were found to be in excellent condition with no evidence of having been disassociated from one another after implantation.Medical records received and evaluation: not performed as no medical records were made available.Device history review: the reported device was manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events reported for this manufacturing lot.Conclusions: the investigation concluded that the exact cause of the event could not be determined because further information such as pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation.It was also concluded that there is no indication the event is related to a manufacturing issue.

Event Description

It was reported that bipolar cup was implanted in (b)(6) 2014.On (b)(6), bipolar cup separated from the inner head when the patient woke up.Revision surgery was performed on (b)(6).

• Brand Name: 22.2MM STD V40 HEAD
• 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: 4459767
• MDR Text Key: 5182077
• Report Number: 0002249697-2015-00234
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K993601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 6260-4-122
• Device Lot Number: 48690604
• Other Device ID Number: STERILE LOT# 1407NCM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 01/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2014
• 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): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 38