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

Catalog Number	6021-0537
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414); Metal Related Pathology (4530)
Date of Event	08/15/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Not returned.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2005 and the femoral head was explanted on (b)(6) 2013.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue and excessive levels of chromium and cobalt in his blood.
Additional Manufacturer Narrative
An event regarding abnormal ion level involving an accolade stem was reported.The event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: a revision surgery was performed for a fracture of an alumina head after a patient fall.This was approximately 8 years after the primary ceramic on ceramic tha.The stem was preserved at revision despite gouges in the trunnion.A new v40 cocr head was placed with a new polyethylene liner.No medical records or patient history provided after the revision.Only the op note provided preop.No mention or re-revision or increased metal levels.Event confirmation: a primary ceramic-ceramic tha can be confirmed.A revision for fracture of a ceramic head can be confirmed.Re-revision cannot be confirmed.Patient injury, excessive metal levels and/or device recall cannot be confirmed." product history review: review of the device history records indicate 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 lot referenced.Conclusions: it was reported that the patient was revised due to fracture of the ceramic head.A review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: a revision surgery was performed for a fracture of an alumina head after a patient fall.This was approximately 8 years after the primary ceramic on ceramic tha.The stem was preserved at revision despite gouges in the trunnion.A new v40 cocr head was placed with a new polyethylene liner.No medical records or patient history provided after the revision.Only the op note provided preop.No mention or re-revision or increased metal levels.Event confirmation: a primary ceramic-ceramic tha can be confirmed.A revision for fracture of a ceramic head can be confirmed.Re-revision cannot be confirmed.Patient injury, excessive metal levels and/or device recall cannot be confirmed." although the root cause could not be determined from the information provided, it is likely that trauma contributed to fracture of the ceramic head as it was reported that the patient had a hard fall leading up to the revision.It is likely that metallosis/damage to the stem is concomitant to the fractured ceramic head as it was stated that the stem trunnion became damaged and articulated against the liner due to the head fracture event.However, as excessive levels of chromium and cobalt were initially alleged, a full investigation was performed on this device.No further investigation for this event is possible at this time.If devices and/or additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about on (b)(6) 2005 and the femoral head was explanted on (b)(6) 2013.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue and excessive levels of chromium and cobalt in his blood.Update per medical records received: the patient was revised due to fracture of the ceramic head.The patient had fallen one month prior to the revision, landing hard on his left hip, and that is when the pain and popping and catching in the hip began.Damage to the stem trunnion was reported as a result of the femoral stem articulating against the ceramic liner following breakage of the ceramic head.The ceramic liner and ceramic head were revised and the stem and shell were left implanted.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9689211
• Report Number: 0002249697-2020-00250
• Device Sequence Number: 3341130
• Product Code: LPH
• UDI-Device Identifier: 04546540510709
• UDI-Public: 04546540510709
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: 05/31/2009
• Device Catalogue Number: 6021-0537
• Device Lot Number: 9211301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2004
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male