MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-0230
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	10/19/2022
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.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Pt.Scheduled for right revision hip.Res mod 115 stem, 19+20 cone body replaced accolade 1 size 2 femoral stem.36 metal head removed in conjunction with 36 elevated rim ploy insert.Original acetabular cup remained in patient.Converted 36 elevated poly liner to mdm shell/liner with 28+4 biolox ceramic head.Metallosis could be evident based off incision exposure of hip joint tissue/bone and wear on femoral implant neck trunnion.
Event or Problem Description
Pt.Scheduled for right revision hip.Res mod 115 stem, 19+20 cone body replaced accolade 1 size 2 femoral stem.36 metal head removed in conjunction with 36 elevated rim ploy insert.Original acetabular cup remained in patient.Converted 36 elevated poly liner to mdm shell/liner with 28+4 biolox ceramic head.Metallosis could be evident based off incision exposure of hip joint tissue/bone and wear on femoral implant neck trunnion.
Additional Manufacturer Narrative
Reported event: an event regarding wear/metallosis and abnormal ion level involving a metal head that was mated with an accolade stem was reported.Wear/metallosis was confirmed via clinician review of the provided medical records.Abnormal ion level was not confirmed.Method & results -product evaluation and results: the stem trunnion is worn.Damage consistent with loss of taper lock.Damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of capa.No further material analyses were performed.-clinician review: a review of the provided medical information by a clinical consultant indicated: conclusion of assessment: a revision surgery was performed for metallosis with bone and tissue loss.Significant bone loss was seen intraoperatively and trunnion corrosion with implant metal loss of the trunnion and neck were noted.Metal levels were cited but not provided in the medical record.Device or procedure related adverse event: revision surgery for trunnionosis root cause and confirmation: a revision surgery can be confirmed.Metallosis and bone loss can be confirmed.Trunnion wear was confirmed in the operative note.Increased metal levels cannot be confirmed.The root cause appeared to be trunnionosis via a corrosive mechanism between the tmzf stem and the lfit head.-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: a review of the provided medical information by a clinical consultant indicated: conclusion of assessment: a revision surgery was performed for metallosis with bone and tissue loss.Significant bone loss was seen intraoperatively and trunnion corrosion with implant metal loss of the trunnion and neck were noted.Metal levels were cited but not provided in the medical record.Device or procedure related adverse event: revision surgery for trunnionosis root cause and confirmation: a revision surgery can be confirmed.Metallosis and bone loss can be confirmed.Trunnion wear was confirmed in the operative note.Increased metal levels cannot be confirmed.The root cause appeared to be trunnionosis via a corrosive mechanism between the tmzf stem and the lfit head.The stem trunnion is worn.Damage consistent with loss of taper lock.Damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.This has been documented as part of capa.The reported accolade stem was mated with a lfit v40 cocr head.The cocr head has been identified to be within scope of nc and capa.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ACCOLADE TMZF HIP STEM #2
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15785314
• Report Number: 0002249697-2022-01611
• Device Sequence Number: 16903647
• Product Code: LPH
• UDI-Device Identifier: 04546540510549
• UDI-Public: 04546540510549
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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: 07/31/2011
• Device Model Number: 6020-0230
• Device Catalogue Number: 6020-0230
• Device Lot Number: 19036201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2006
• 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: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female