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

Catalog Number	6020-0537
Medical Device Problem Codes	Corroded (1131); Degraded (1153); Disassembly (1168)
Health Effect - Clinical Codes	Injury (2348); Osteolysis (2377); Reaction (2414)
Date of Event	05/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion: cup malposition in near absent anteversion has contributed to an overload condition in the arthroplasty, especially near the trunnion section causing secondary corrosion between femoral head and stem taper leading to progressive metal substance loss with metallosis in the joint space, loss of taper lock and ultimately disassociation between stem trunnion and femoral head requiring revision.Additionally, there is osteolysis around the proximal stem section although the stem remains well fixed in the more distal parts.Also around the cup is osteolysis evident, especially around the supplemental screw fixation although also the cup still appears stable in the bone near the periphery.Not returned.
Event or Problem Description
It was reported that on (b)(6) 2018, dr.(b)(6) performed a revision of an accolade stem with a dislocated femoral head component as visible by preop x-ray.Update per med review: cup malposition in near absent anteversion has contributed to an overload condition in the arthroplasty, especially near the trunnion section causing secondary corrosion between femoral head and stem taper leading to progressive metal substance loss with metallosis in the joint space, loss of taper lock and ultimately disassociation between stem trunnion and femoral head requiring revision.Additionally, there is osteolysis around the proximal stem section although the stem remains well fixed in the more distal parts.Also around the cup is osteolysis evident, especially around the supplemental screw fixation although also the cup still appears stable in the bone near the periphery.
Additional Manufacturer Narrative
An event regarding wear, disassociation, osteolysis and corrosion involving an accolade stem was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection: visual inspection of the returned device indicates the presence of biological material, wear of the trunnion and explantation damage.Dimensional inspection & functional inspection: not performed as there is evidence from the visual inspection that the device is damaged.Material analysis: material analysis was not performed due to the nature of the event medical records received and evaluation: a review of the provided medical records and x-ray by a clinical consultant indicated: the visible osteolysis around the proximal stem and around the screw sixation of the cup shell is consistent with such an overload condition.Cup malposition in near absent anteversion has contributed to an overload condition in the arthroplasty, especially near the trunnion section causing secondary corrosion between femoral head and stem taper leading to progressive metal substance loss with metallosis in the joint space, loss of taper lock and ultimately disassociation between stem trunnion and femoral head requiring revision.Device history review: 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 reported lot.Conclusion: the investigation concluded that cup malposition in near absent anteversion has contributed to an overload condition in the arthroplasty, especially near the trunnion section causing secondary corrosion between femoral head and stem taper leading to progressive metal substance loss with metallosis in the joint space, loss of taper lock and ultimately disassociation between stem trunnion and femoral head requiring revision.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
It was reported that on (b)(6) 2018, dr.(b)(6) performed a revision of an accolade stem with a dislocated femoral head component as visible by preop x-ray.Update per med review: cup malposition in near absent anteversion has contributed to an overload condition in the arthroplasty, especially near the trunnion section causing secondary corrosion between femoral head and stem taper leading to progressive metal substance loss with metallosis in the joint space, loss of taper lock and ultimately disassociation between stem trunnion and femoral head requiring revision.Additionally, there is osteolysis around the proximal stem section although the stem remains well fixed in the more distal parts.Also around the cup is osteolysis evident, especially around the supplemental screw fixation although also the cup still appears stable in the bone near the periphery.

• Brand Name: ACCOLADE 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: 7620182
• Report Number: 0002249697-2018-01897
• Device Sequence Number: 19187881
• Product Code: LPH
• UDI-Device Identifier: 04546540510570
• UDI-Public: 04546540510570
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

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: 07/31/2014
• Device Catalogue Number: 6020-0537
• Device Lot Number: 30057604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 08/29/2018
• 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; Other; Required Intervention
• Patient Age: 67 YR