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 Codes	Foreign Body Reaction (1868); Ambulation or Postural Difficulties (2544)
Date of Event	01/25/2022
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.Catalog numbers and lot codes of other devices listed in this report: oem - mitch shell; cat#unknown ; lot#unknown.Oem - mitch head; cat#unknown ; lot#unknown.Device not returned to the manufacturer.
Event or Problem Description
Patient had severe metallosis, trunnionosis.Surgeon noted that the trunnion was severely worn down and the head fell off the stem.Right side.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and wear/metallosis involving an accolade stem was reported.The event was confirmed through material analysis of the returned device.Method & results: product evaluation and results: the stem was returned for evaluation, damage is visible on the stem consistent with in vivo use and explantation damage.The trunnion of the stem is worn/corroded.Damage consistent with the loss of taper lock was observed on the stem.No further material analyses were performed.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review the information related to pi including the product inquiry summary, x-ray reports, multiple microbiology reports, pathology report, an intra-operative photograph and a handwritten brief operative report.The event description for this pi states: patient had severe metallosis, trunnionosis.Surgeon noted that the trunion was severely worn down and the head fell off the stem.The documentation provided confirms that a revision surgery was performed for dissociation of the head from the trunnion.There was gross deformity of the trunnion with significant material loss.The operative report and pathology report further confirm metallosis within the joint tissue.The root cause for this event cannot be determined from this limited documentation.Should additional information become available i would be happy to further this review.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.Conclusion: the stem was returned for evaluation, damage is visible on the stem consistent with in vivo use and explantation damage.The trunnion of the stem is worn/corroded.Damage consistent with the loss of taper lock was observed on the stem.No further material analyses were performed.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.
Event or Problem Description
Patient had severe metallosis, trunnionosis.Surgeon noted that the trunion was severely worn down and the head fell off the stem.Right side.

• 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 13521920
• Report Number: 0002249697-2022-00229
• Device Sequence Number: 17183233
• Product Code: LPH
• UDI-Device Identifier: 04546540510747
• UDI-Public: 04546540510747
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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: 02/28/2012
• Device Model Number: 6021-2530
• Device Catalogue Number: 6021-2530
• Device Lot Number: 21676502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2007
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 78 KG