MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-0435
Medical Device Problem Codes	Degraded (1153); Material Erosion (1214)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
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 her right hip on or about (b)(6) 2011 and was revised on (b)(6) 2022.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in her blood.
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.
Additional Manufacturer Narrative
Reported event: an event regarding abnormal ion level involving a 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 was not returned.-medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: the implant sheet confirms that the patient had a cocr v40 femoral head implanted.No evidence was presented to support the other claims in the event description.With this limited information the root cause of this issue cannot be determined.Should additional information become available i would be happy to further this assessment.-product history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there has been 1 other event for the reported lot.Conclusions: it was reported that the patient suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.A review of the provided medical information by a clinical consultant indicated: the implant sheet confirms that the patient had a cocr v40 femoral head implanted.No evidence was presented to support the other claims in the event description.With this limited information the root cause of this issue cannot be determined.Should additional information become available i would be happy to further this assessment.The medical records provided for review were insufficient to confirm the reported events or determine root cause.Further information such as return of the device, 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.No further investigation for this event is possible at this time.If devices and / or additional information become 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 her right hip on or about (b)(6), 2011 and was revised on (b)(6), 2022.It is further alleged that she suffered injuries as a result of implantation and explantation of the device at issue, device recall and excessive levels of chromium and cobalt in her blood.

• Brand Name: ACCOLADE TMZF HIP STEM #4
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 14615937
• Report Number: 0002249697-2022-00801
• Device Sequence Number: 5014056
• Product Code: LPH
• UDI-Device Identifier: 04546540510563
• UDI-Public: 04546540510563
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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: 02/28/2016
• Device Model Number: 6020-0435
• Device Catalogue Number: 6020-0435
• Device Lot Number: 36006203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2011
• 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 Sex: Female