MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-0335
Medical Device Problem Codes	Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); No Information (3190)
Date of Event	11/25/2020
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
Patient presented to the orthopaedic oncologist with a pseudo-tumor around the head/trunnion junction of her stem.Patient underwent a revision hip procedure.The pseudo-tumor was removed and a new femoral head and acetabular liner were put in.Update 03dec2020 - as per sales rep email, "the stem was not revised, and the cup and liner were stryker.The liner was replaced only because he was there and he felt like it was necessary because of the metallosis it was exposed to.".
Additional Manufacturer Narrative
Reported event: an event regarding altr 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.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: confirmation: the event cannot be confirmed.There are not enough data to confirm the presence of metallosis or trunnionosis.However, it does appear that a revision was performed with head and polyethylene swap.Root cause: the assertion was that there was trunnionosis/metallosis.Medical records, operative records, and history would add to the assessment.When the revision was performed pathology and intraoperative findings would help the assessment.Obtaining the retrieved head and confirming the lot number and add to the assessment.Product history review: indicated 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 lot referenced.Conclusions: based on the medical review comment of the provided information the event cannot be confirmed as insufficient information was provided.Further information such as operative reports, medical records, medical history, pathology reports, intraoperative findings as well as return of the device are needed to fully investigate the event.It is noted that the customer is inquiring if the device reported is subject to a product recall.The device reported in this complaint investigation is not subject to a product recall.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Patient presented to the orthopaedic oncologist with a pseudo-tumor around the head/trunnion junction of her stem.Patient underwent a revision hip procedure.The pseudo-tumor was removed and a new femoral head and acetabular liner were put in.Update 03dec2020 - as per sales rep email, "the stem was not revised, and the cup and liner were stryker.The liner was replaced only because he was there and he felt like it was necessary because of the metalosis it was exposed to.".

• Brand Name: ACCOLADE TMZF HIP STEM #3
• 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: 11011695
• Report Number: 0002249697-2020-02684
• Device Sequence Number: 753289
• Product Code: LPH
• UDI-Device Identifier: 04546540510556
• UDI-Public: 04546540510556
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: 09/30/2017
• Device Model Number: 6020-0335
• Device Catalogue Number: 6020-0335
• Device Lot Number: 41233002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/21/2021
• 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: 82 YR
• Patient Weight: 61