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

Catalog Number	6020-0435
Medical Device Problem Codes	Degraded (1153); Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary tha surgery was done at (b)(6) 2011.Unable to walk due to broken implant.Revision surgery is scheduled at (b)(6) 2023.
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.H3 other text : device not returned.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation and wear involving an accolade stem was reported.The event was confirmed via evaluation of the provided photographs of the stem and clinician review of the provided medical records.Method & results: -product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the stem indicated the device is covered in blood and bodily tissue and the damage consistent with loss of taper lock.-clinician review: a review of the provided medical information by a clinical consultant indicated: "the ap pelvis x-ray shows a dissociated left tha with remodeling and material loss on the trunnion.The photograph of the explanted stem shows remodeling and material loss on the trunnion.The intra-op photograph again shows remodeling and material loss on the trunnion.The ap hip x-ray shows a right tha with remodeling and material loss on the trunnion.Neither x-ray was dated or marked with laterality so although they are similar in appearance i can not be sure if they are of the same patient.It is confirmed that a patient had dissociation of atha with marked trunnionosis and material loss with deformity.The root cause of the trunnionosis cannot be determined from the limited documentation provided.-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: it was reported that the patient was revised due to disassociation of the femoral head from the stem.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photographs of the stem indicated the device is covered in blood and bodily tissue and the damage consistent with loss of taper lock.A review of the provided medical information by a clinical consultant indicated: "the ap pelvis x-ray shows a dissociated left tha with remodeling and material loss on the trunnion.The photograph of the explanted stem shows remodeling and material loss on the trunnion.The intra-op photograph again shows remodeling and material loss on the trunnion.The ap hip x-ray shows a right tha with remodeling and material loss on the trunnion.Neither x-ray was dated or marked with laterality so although they are similar in appearance i can not be sure if they are of the same patient.It is confirmed that a patient had dissociation of atha with marked trunnionosis and material loss with deformity.The root cause of the trunnionosis cannot be determined from the limited documentation provided." 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
Primary tha surgery was done at (b)(6) 2011.Unable to walk due to broken implant.Revision surgery is scheduled at (b)(6) 2023.Updated information: a month ago, he staggered and fell on a fishing boat, and since then he has been feeling discomfort from his hip to his right hip.(b)(6) when i got up from my chair, my legs felt wobbly.When he lay down and tried to get up, he developed pain in his right hip and had difficulty moving.As a result of a visit to the primary care physician, a tha dislocation was found and the patient was transferred to the main hospital.

• 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: 17726527
• Report Number: 0002249697-2023-01022
• Device Sequence Number: 17676008
• Product Code: LPH
• UDI-Device Identifier: 04546540510563
• UDI-Public: 04546540510563
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023

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: 04/30/2016
• Device Catalogue Number: 6020-0435
• Device Lot Number: 36686706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2011
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 71 KG