MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 44MM/-4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6260-9-044

Device Problems Corroded (1131); Material Discolored (1170); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Fatigue (1849); Pain (1994); Swelling (2091); Injury (2348); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671)

Event Date 12/14/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient underwent revision surgery of an accolade 1 and lfit head due to trunnionosis.Reported hip swelling, difficulty in mobilising due to pain in hip, low energy and anaemia.

Manufacturer Narrative

Additional information: brand name; product code; common device name; catalog #; lot #, expiration date; returned to manufacturer on; pma/510(k) #; device manufacture date.An event regarding alleged ¿pain, swelling and corrosion¿ involving a metal head was reported.The event was confirmed.Method & results: device evaluation and results: material analysis was performed and concluded that ¿discoloration was observed in the taper of the head.Eds showed the discoloration was consistent with a corrosion process, material transfer from a hip stem and biological material.No material or manufacturing defects were observed on the surfaces examined.¿ medical records received and evaluation: a review of provided revision operative report, lab reports, and material analysis of the explanted metal head by a clinical consultant by a clinical consultant indicated ¿no complete clinical or past medical history or patient demographics are available.There are no x-rays available for review and no serum cobalt and chromium levels or mars mri images of either hip.There is no examination of the right hip explanted components and no histologic slides available for evaluation.After multiple revisions to both hips, compromised soft and bony tissue and possible infection, histologic diagnosis confirming trunnionosis as the source of pathology and histologic findings is properly listed as ¿opinion¿.Review of additional documentation and review of histologic slides is required to evaluate this case.¿ device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the event was confirmed.However, the root cause could not be determined based on the review of the provided revision operative report, lab reports, and material analysis of the explanted metal head on the left hip by a clinical consultant indicating: ¿no complete clinical or past medical history or patient demographics are available.There are no x-rays available for review and no serum cobalt and chromium levels or mars mri images of either hip.There is no examination of the right hip explanted components and no histologic slides available for evaluation.After multiple revisions to both hips, compromised soft and bony tissue and possible infection, histologic diagnosis confirming trunnionosis as the source of pathology and histologic findings is properly listed as ¿opinion¿.Review of additional documentation and review of histologic slides is required to evaluate this case.¿.

Event Description

The patient underwent left hip revision surgery of an accolade 1 and lfit head due to trunnionosis.Reported hip swelling, difficulty in mobilising due to pain in hip, low energy and anaemia.

• Brand Name: V40 COCR LFIT HEAD 44MM/-4
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6241033
• MDR Text Key: 64486076
• Report Number: 0002249697-2017-00168
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K061434
• 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: 11/28/2017

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: 03/31/2014
• Device Catalogue Number: 6260-9-044
• Device Lot Number: MHE1JR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 01/11/2017
• Supplement Dates Manufacturer Received: 10/30/2017
• Supplement Dates FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2009
• 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: 71 YR
• Patient Weight: 88