MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 2 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6721-0230

Device Problem Degraded (1153)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding abnormal ion level involving a accolade stem was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant -product history review: review of the product history records indicate devices were manufactured and accepted into final stock with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported by claimant's counsel that the patient underwent right tha on (b)(6) 2016 and was implanted with an lfit v40 femoral head and an accolade ii hip stem.Subsequently she presented with increasing pain and workup showed elevated cobalt and chromium levels.She was revised on (b)(6) 2022.

• Brand Name: SIZE 2 ACCOLADE II 127 DEG
• 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19162860
• MDR Text Key: 340803798
• Report Number: 0002249697-2024-00627
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540669476
• UDI-Public: 04546540669476
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2024

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: 11/30/2020
• Device Catalogue Number: 6721-0230
• Device Lot Number: 52772503
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2015
• 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; Hospitalization
• Patient Sex: Female