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); Fracture (1260)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Ambulation or Postural Difficulties (2544)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar 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.
Event or Problem Description
Revision of accolade i stem.
Event or Problem Description
Revision of accolade i stem.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a accolade stem was reported.The event was confirmed through visual inspection of the provided photographs.Method & results: product evaluation and results: no product was returned for evaluation however photographs were provided for review.The photographs show a recently explanted, stem attached to a removal instrument.Damage is visible on the body of the stem, the trunnion is fractured off the stem but is visible beside it.The head and liner are also visible.Blood is visible on the head and liner.From the images provided the head and liner appear unremarkable.The intraoperative images are also provided which show black tissue and fluid around the devices.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: the event description states: "revision of accolade i stem.".(b)(6) 2018 x-ray: uncemented right tha reduced, nominal position, cerclage cable around femur 1.5 cm distal to femoral stem tip.Undated x-ray: ap right hip: uncemented tha, modular head in acetabular component, stem trunnion dislocated and disassociated from modular head, distal stem not visualized.Based upon the information available for review, neither confirmation of the event description nor preparation of a medical report is possible for this case.Clinician review of the following documentation.Unlabelled color photo of explanted, blood stained components including femoral stem with fractured, displaced trunnion fragment, intact metal head and polyethylene insert.Color unlabelled intraoperative photos of hip incision demonstrating proximal femoral stem with missing trunnion fragment and black staining material covering soft tissue in depth of incision.Review of this additional information does not allow for preparation of a medical report for this case.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 have been no other similar events for the lot referenced.Conclusions: a review of the provided medical records by a clinical consultant stated the following comment: the event description states: "revision of accolade i stem."(b)(6) 2018 x-ray: uncemented right tha reduced, nominal position, cerclage cable around femur 1.5 cm distal to femoral stem tip.Undated x-ray: ap right hip: uncemented tha, modular head in acetabular component, stem trunnion dislocated and disassociated from modular head, distal stem not visualized.Based upon the information available for review, neither confirmation of the event description nor preparation of a medical report is possible for this case.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device return pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of a capa.No further investigation for this event is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• 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: 11278321
• Report Number: 0002249697-2021-00217
• Device Sequence Number: 14298627
• Product Code: LPH
• UDI-Device Identifier: 04546540510709
• UDI-Public: 04546540510709
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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: 06/30/2014
• Device Model Number: 6021-0537
• Device Catalogue Number: 6021-0537
• Device Lot Number: 30359703
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/04/2021
• 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: 80 YR