MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #5; HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

Model Number	6021-5537
Medical Device Problem Codes	Degraded (1153); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	05/01/2019
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.Device not returned.
Event or Problem Description
It was reported that the patient's right hip was revised due to trunnionosis.Pre-op x-rays show the head disassociated from the stem.Intra-operatively, black tissue was noted in the patient.No liner wear or discoloration were reported.The stem, head and liner were revised to a stryker liner with a competitor stem and head.Rep provided a pre-revision x-ray and reported that no further information will be released by the hospital or surgeon.
Event or Problem Description
T was reported that the patient's right hip was revised due to trunnionosis.Pre-op x-rays show the head disassociated from the stem.Intra-operatively, black tissue was noted in the patient.No liner wear or discoloration were reported.The stem, head and liner were revised to a stryker liner with a competitor stem and head.Rep provided a pre-revision x-ray and reported that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and fretting involving an accolade stem was reported.The event of disassociation was confirmed by clinician review and the event of fretting was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided x-rays by a clinical consultant indicated: " x-ray confirms disassociation; need additional information; primary and revision operative reports, clinical and past medical history, additional serial x-rays".Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the clinician confirmed the event of disassociation but requires addition information to conduct a full medical review.The exact cause of the event could not be determined because insufficient information was provided.Additional information including product details, primary and revision operative reports, clinical and past medical history, additional serial x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Additional Manufacturer Narrative
An event regarding disassociation and fretting involving an accolade stem was reported.The event of disassociation was confirmed by clinician review and the event of fretting was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned.-clinician review: a review of the provided x-rays by a clinical consultant indicated: " x-ray confirms disassociation; need additional information; primary and revision operative reports, clinical and past medical history, additional serial x-rays".-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.-complaint history review: there has been no other event for the lot referenced.Conclusion: the clinician confirmed the event of disassociation but requires addition information to conduct a full medical review.The exact cause of the event could not be determined because insufficient information was provided.Additional information including primary and revision operative reports, clinical and past medical history, additional serial x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
T was reported that the patient's right hip was revised due to trunnionosis.Pre-op x-rays show the head disassociated from the stem.Intra-operatively, black tissue was noted in the patient.No liner wear or discoloration were reported.The stem, head and liner were revised to a stryker liner with a competitor stem and head.Rep provided a pre-revision x-ray and reported that no further information will be released by the hospital or surgeon.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #5
• Common Device Name: HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8648009
• Report Number: 0002249697-2019-02110
• Device Sequence Number: 2212032
• Product Code: LPH
• UDI-Device Identifier: 04546540510778
• UDI-Public: 04546540510778
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2020

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: 01/31/2017
• Device Model Number: 6021-5537
• Device Catalogue Number: 6021-0537
• Device Lot Number: 38182805
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 06/21/2019; 08/26/2020
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 07/19/2019; 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention