MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE 1; HIP IMPLANT

Catalog Number UNK_SHC

Device Problems Corroded (1131); Material Deformation (2976); Appropriate Term/Code Not Available (3191)

Patient Problems Anemia (1706); Swelling (2091); Injury (2348); Arthralgia (2355); Joint Swelling (2356); 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

An event regarding alleged ¿pain and swelling¿ involving an unknown accolade stem was reported.The reported event for corrosion was confirmed based on material analysis report for the metal head.Device evaluation and results: not performed as the device was not returned.Medical records received and evaluation: a review of provided revision operative report, lab reports, and material analysis of the explanted metal head on the left hip 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: not performed as the device was not properly identified.Complaint history review: not performed as the device was not properly identified.Conclusions: the reported event for corrosion was confirmed based on review of the material analysis report of the metal head stating that "eds showed the discoloration was consistent with a corrosion process, material transfer from a hip stem and biological material." the root cause could not be determined based on review of the provided revision operative report, and lab reports 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.¿ not available.

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: UNKNOWN ACCOLADE 1
• Type of Device: HIP IMPLANT
• 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: 6241001
• MDR Text Key: 64481709
• Report Number: 0002249697-2017-00167
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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