MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 22.2MM + 3MM V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6260-4-222

Device Problems Material Deformation (2976); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Toxicity (2333); Injury (2348); Reaction (2414)

Event Date 12/30/2016

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Patient complained of right hip pain.Doctor stated patient had increase of high ion levels.

Manufacturer Narrative

An event regarding alleged "damage" involving a metal head was reported.The event was confirmed.-device evaluation and results: material analysis was performed and concluded "damages consistent with impingement and explantation were observed on the constrained insert.Damage consistent with explantation, was observed on the v40 head.No material or manufacturing defects were observed on the surfaces examined." -medical records received and evaluation: a review of the medical records by the consulting clinician indicated "there are no patient demographics, no x-rays and no clinical or past medical history, and no (b)(6) 2016 second revision operative report is available for review.When a constrained liner is utilized for recurrent hip dislocation, if the instability was due to impingement, malposition or soft tissue inadequacy, there will be repeated impingement on the locking device of the constrained liner.After five-and-a-half years in situ the locking mechanism failed due to impingement damage.The event description states: ¿doctor stated patient had increase of high ion levels¿.There is no documentation confirming this statement.There is no evidence of manufacturing or material defects observed." -device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusions: the event was confirmed.However, the root cause could not be determined based on the medical review by the consulting clinician: "there are no patient demographics, no x-rays and no clinical or past medical history, and no (b)(6) 2016 second revision operative report is available for review.When a constrained liner is utilized for recurrent hip dislocation, if the instability was due to impingement, malposition or soft tissue inadequacy, there will be repeated impingement on the locking device of the constrained liner.After five-and-a-half years in situ the locking mechanism failed due to impingement damage.The event description states: ¿doctor stated patient had increase of high ion levels¿.There is no documentation confirming this statement.There is no evidence of manufacturing or material defects observed." if additional information is received, this investigation will be reopened and re-evaluated.

Event Description

Patient complained of right hip pain.Doctor stated patient had increase of high ion levels.Update per review of the medical review: "damages consistent with impingement and explantation were observed on the constrained insert.Damage consistent with impingement was observed on the v-40 head.".

• Brand Name: 22.2MM + 3MM V40 HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: suzanne neuschwanter ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6272600
• MDR Text Key: 65588942
• Report Number: 0002249697-2017-00302
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2017

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: 03/31/2013
• Device Catalogue Number: 6260-4-222
• Device Lot Number: 25937804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2016
• Initial Date FDA Received: 01/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2008
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR