MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #6; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6021-0637
Medical Device Problem Codes	Degraded (1153); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Joint Dislocation (2374); Reaction (2414)
Date of Event	09/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.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
Patient was fixing a deck and experienced severe pain in his hip and could not move without pain.Update 10/september/2018: as cited in "adverse consequences details": patient required revision surgery.It was repeorted that the head disassociated from the stem.A considerable amount of black tissue was present in the joint.Pre-revision x-rays and an explant picture were provided.
Event or Problem Description
Patient was fixing a deck and experienced severe pain in his hip and could not move without pain.Update 10/september/2018: as cited in "adverse consequences details": patient required revision surgery.It was repeorted that the head disassociated from the stem.A considerable amount of black tissue was present in the joint.Pre-revision x-rays and an explant picture were provided.
Additional Manufacturer Narrative
Adding investigation conclusion; reported event: an event regarding disassociation & altr involving an accolade stem was reported.Disassociation was confirmed.Altr was not confirmed.Method & results: -product evaluation and results: the device was not returned however a photo was provided which noted wear on the trunnion of the stem and biological material on the coated segment.-medical records received and evaluation: a review of the provided medical records by a clinical physician was rejected stating [.] rejected for medical review by dr.Jaffe today - x-ray and photo confirm event of disassociation and trunnion erosion/corrosion; need operative reports, clinical/past medical history, examination of explanted components[.] -product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there were no other events for the lot provided.Conclusion: disassociation was confirmed by a clinician on review of the provided photos & x-ray however altr was not confirmed.Further information such as return of device, patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #6
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7937984
• Report Number: 0002249697-2018-03217
• Device Sequence Number: 13937285
• Product Code: LPH
• UDI-Device Identifier: 04546540510716
• UDI-Public: 04546540510716
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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: 04/30/2011
• Device Catalogue Number: 6021-0637
• Device Lot Number: 18035703
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 11/29/2018
• 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
• Patient Age: 68 YR