MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-2530
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530)
Date of Event	01/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic v40 femoral head on her right hip on or about (b)(6) 2012 and was revised on (b)(6) 2020.It is further alleged that she suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in her blood.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic v40 femoral head on her right hip on or about (b)(6), 2012 and was revised on (b)(6), 2020.It is further alleged that she suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in her blood.Update 03-17-2022: head disassociation: *update on 28-apr-2022 based on medical review: "[.] the next page is dated (b)(6), 2020 from medical center.An x-ray was taken showing the disassociation.An operation note dated (b)(6), 2020 by dr.[.] the postoperative diagnosis was "right hip prosthetic joint disassociation, felt secondary to trunnionosis, abductor repair failure and extensive pseudo-tumor about the hip joint capsule with extensive metal debris." the operation report is reviewed.The surgeon noted extensive trunnionosis with significant muscle damage.[.] ".
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and abnormal ion level/ altr involving an accolade stem was reported.The event was confirmed via clinician review.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: a review of the provided medical information by a clinical consultant indicated: this inquiry reports the failure of a total hip arthroplasty about 8 years after implantation due to trunnionosis and head disassociation associated with elevated metal ion levels.I can confirm that this event took place since i was able to review the revision operation report.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of trunnionosis and disassociation are multifactorial including surgical technique factors, patient factors, and implant factors.-product history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient's hip was revised due to excessive levels of chromium and cobalt in her blood, right hip prosthetic joint disassociation, felt secondary to trunnionosis, abductor repair failure and extensive pseudo-tumor about the hip joint capsule with extensive metal debris.The event was confirmed via clinician review.The exact cause of the event could not be determined.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.

• Brand Name: ACCOLADE 132 SIZE 2.5
• Common Device Name: 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 13573621
• Report Number: 0002249697-2022-00258
• Device Sequence Number: 17569499
• Product Code: LPH
• UDI-Device Identifier: 04546540510617
• UDI-Public: 04546540510617
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: 6020-2530
• Device Catalogue Number: 6020-2530
• Device Lot Number: 38601906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female