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

Model Number	6021-0537
Medical Device Problem Codes	Material Erosion (1214); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Joint Dislocation (2374); Reaction (2414); Ambulation or Postural Difficulties (2544)
Date of Event	01/18/2020
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 left hip was revised due to disassociation of the femoral head from the stem.Upon opening the hip capsule, surgeon reported the existence of metallosis.There was excessive gray fluid in the capsule, and significant wear of the trunnion was observed.The stem, head, and liner were revised to a restoration modular stem construct with a ceramic head and mdm/ adm liner construct.Rep confirmed there are no allegations against the revised liner, and provided explant pictures and pre-revision x-rays.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation of the femoral head from the stem was reported.Upon opening the hip capsule, surgeon reported the existence of metallosis and significant wear of the trunnion.The event of disassociation was confirmed through clinician review of the provided x-rays.Wear/fretting/metallosis was not confirmed.Method & results: product evaluation and results: no product was returned for evaluation however, one photograph was provided for review.The photograph shows a recently explanted stem with tissue/blood around the stem body.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: provided x-ray images confirm disassociation, need additional information; primary and revision operative reports, clinical and past medical history, and examination of explanted components.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 event of disassociation was confirmed through clinician review of the provided x-rays.Corrosion/wear and metallosis were not confirmed.The exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as primary and revision operative reports, clinical and past medical history as well as device lot information and return are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
Event or Problem Description
It was reported that the patient's left hip was revised due to disassociation of the femoral head from the stem.Upon opening the hip capsule, surgeon reported the existence of metallosis.There was excessive gray fluid in the capsule, and significant wear of the trunnion was observed.The stem, head, and liner were revised to a restoration modular stem construct with a ceramic head and mdm/ adm liner construct.Rep confirmed there are no allegations against the revised liner, and provided explant pictures and pre-revision x-rays.

• Brand Name: ACCOLADE PLUS 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: 9711256
• Report Number: 0002249697-2020-00300
• Device Sequence Number: 16635273
• Product Code: LPH
• UDI-Device Identifier: 04546540510709
• UDI-Public: 04546540510709
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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 Model Number: 6021-0537
• Device Catalogue Number: 6021-0537
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 04/01/2020
• 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: 71 YR