MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6021-2530
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left hip was revised.As reported by rep: "the patient came to dr on (b)(6) 2021, after seeing a chiropractor, complaining of hip pain.An x-ray revealed a severely worn trunnion.During surgery it was noted the trunion had severe wear.A restoration modular stem was used as the replacement device." rep provided an x-ray showing the head dissociated from the stem.
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
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.Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
It was reported that the patient's left hip was revised.As reported by rep: "the patient came to dr on (b)(6) 2021, after seeing a chiropractor, complaining of hip pain.An x-ray revealed a severely worn trunnion.During surgery it was noted the trunion had severe wear.A restoration modular stem was used as the replacement device." rep provided an x-ray showing the head dissociated from the stem.
Event or Problem Description
It was reported that the patient's left hip was revised.As reported by rep: "the patient came to dr on (b)(6), 2021, after seeing a chiropractor, complaining of hip pain.An x-ray revealed a severely worn trunnion.During surgery it was noted the trunion had severe wear.A restoration modular stem was used as the replacement device." rep provided an x-ray showing the head dissociated from the stem.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving an accolade stem was reported.The event was confirmed.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photograph indicated that the devices appear recently explanted and are covered in blood/tissue.The stem trunnion is severely worn.Damage is consistent with loss of taper lock.-clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion of assessment: this inquiry reports the failure of an accolade femoral component about 10 years after implantation due to head/neck disassociation and trunnion wear.I can confirm that the head/neck disassociation took place since i was able to see an x-ray confirming this.I cannot confirm that revision was performed as i have supporting documentation such as office notes, hospital records or operation note.The representative who attended the revision may be able to confirm.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of head/neck disassociation and trunnion wear are multifactorial including surgical technique factors, implant factors and patient factors including weight and activity level." -product history review: review of the device history records indicate 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 was revised due to disassociation of the head from the stem.The event was confirmed by visual inspection of a provided photograph of the devices and by clinician review of the provided x-ray.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13392400
• Report Number: 0002249697-2022-00152
• Device Sequence Number: 4525100
• Product Code: LPH
• UDI-Device Identifier: 04546540510747
• UDI-Public: 04546540510747
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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: 12/31/2016
• Device Model Number: 6021-2530
• Device Catalogue Number: 6021-2530
• Device Lot Number: 38748703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2011
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 93 KG