MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-0537
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348)
Date of Event	04/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, 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.Intra-operative observations reported to the rep: a moderate amount of black tissue, the trunnion was worn and cracked off.The liner was discolored.The portion of the stem inside the head was removed with difficulty.
Event or Problem Description
It was reported that the patient's right hip was revised.Intra-operative observations reported to the rep: a moderate amount of black tissue, the trunnion was worn and cracked off.The liner was discolored.The portion of the stem inside the head was removed with difficulty.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and crack / fracture involving accolade stem was reported.The event was confirmed based on medical record.Method & results: device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted accolade stem with damage at the base of the trunnion and debris can be seen on the surface of the stem.Material analysis,functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records and x-rays by a clinical consultant was rejected indicating: undated, unlabelled x-ray ap right hip demonstrates uncemented tha with stem disassociated and dislocated from head with transverse defect at base of trunnion.Head remains in acetabular component.No clinical or pmh, no operative reports, no examination of explanted components, no serial imaging studies.The x-ray confirms the event description, but a medical report is not possible based upon this single x-ray.Device history review: all 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 reported lot.Conclusion: it was reported that the patient's right hip was revised due to disassociation and crack / fracture of the device.The event was confirmed based on medical record.A review of the provided medical records and x-rays by a clinical consultant was rejected indicating: undated, unlabelled x-ray ap right hip demonstrates uncemented tha with stem disassociated and dislocated from head with transverse defect at base of trunnion.Head remains in acetabular component.No clinical or pmh, no operative reports, no examination of explanted components, no serial imaging studies.The x-ray confirms the event description, but a medical report is not possible based upon this single x-ray.The reported device was not returned however photographs were provided for review.The photographs shows a recently explanted accolade stem with damage at the base of the trunnion and debris can be seen on the surface of the stem.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, 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.H3 other text: device not returned.

• Brand Name: ACCOLADE TMZF HIP STEM #5
• 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: 10065859
• Report Number: 0002249697-2020-00909
• Device Sequence Number: 13647435
• Product Code: LPH
• UDI-Device Identifier: 04546540510570
• UDI-Public: 04546540510570
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2020

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: 07/31/2015
• Device Model Number: 6020-0537
• Device Catalogue Number: 6020-0537
• Device Lot Number: 33883905
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 07/14/2020
• 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
• Patient Age: 87 YR
• Patient Weight: 73