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

Model Number	6020-0537
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Fall (1848); Ambulation or Postural Difficulties (2544)
Date of Event	09/07/2021
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.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.
Event or Problem Description
It was reported that the patient's right hip was revised.The patient had fallen and the head disassociated from the stem.Intraoperatively, the surgeon noticed that there was a lot of wear around the trunnion.Rep noted that "the tip of the trunnion was gone." rep has the implants for return.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving accolade stem was reported.The event was confirmed based on inspection.Method & results: device evaluation and results: visual inspection: visual inspection was performed as part of the material evaluation and indicated the following comments: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.No further material analyses were performed.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Ma: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.No further material analyses were performed.Clinician review: no medical records were received for review with a clinical consultant.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: it was reported that the patient's right hip was revised.The patient had fallen and the head disassociated from the stem.The event was confirmed based on inspection.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.
Event or Problem Description
It was reported that the patient's right hip was revised.The patient had fallen and the head disassociated from the stem.Intraoperatively, the surgeon noticed that there was a lot of wear around the trunnion.Rep noted that "the tip of the trunnion was gone." rep has the implants for return.
Additional Manufacturer Narrative
Additional information received on the 14/march/2022 which included medwatch report number (b)(4).Reported event: an event regarding disassociation involving an accolade stem was reported.The event was confirmed based on product inspection.Method & results: device evaluation and results: damage consistent with the loss of taper lock was observed on the head and stem of the returned devices.No further material analyses were performed.Clinician review: no medical records were received for review with a clinical consultant.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: it was reported that the patient's right hip was revised.The patient had fallen and the head disassociated from the stem.He event was confirmed based on product inspection.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.
Event or Problem Description
It was reported that the patient's right hip was revised.The patient had fallen and the head disassociated from the stem.Intraoperatively, the surgeon noticed that there was a lot of wear around the trunnion.Rep noted that "the tip of the trunnion was gone." rep has the implants for return.Update 14/march/2022 (b)(6): as reported in medwatch (b)(4): patient came in to emergency department with hip issue and was found to have potential failed hip hardware/ dislocation.Patient was transferred to another hospital and taken to or two days later.Hip explants removed (stem/ liner/ head).Sent to manufacturer (via representative) for evaluation per surgeon request.Stryker accolade femoral stem: lot number 11317102.Stryker femoral head 32 +4: lot number 26420501.Stryker liner size 32 10 degree - no lot number visible.

• 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
• 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: 12554364
• Report Number: 0002249697-2021-01653
• Device Sequence Number: 4461034
• Product Code: LPH
• UDI-Device Identifier: 04546540510570
• UDI-Public: 04546540510570
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2022

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: 01/31/2010
• Device Model Number: 6020-0537
• Device Catalogue Number: 6020-0537
• Device Lot Number: 11317102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 10/22/2021; 03/23/2022
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 11/17/2021; 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2005
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 111 KG