MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4 ACCOLADE II 127 DEG; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6721-0435
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's right hip was revised due to thigh pain and start-up pain.The stem, head, and liner were revised to a restoration modular stem construct, femoral head, mdm/ adm poly insert, and mdm metal liner.Rep confirmed that stem was not noted to be loose, and that the surgeon 'had to work to get it out.' the reason for converting the liner to mdm was not reported to the rep, rep reported that the hip was stable with the original liner.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
The following devices were also listed in this report: delta v-40 ceramic head 36/-2,5; cat # 6570-0-436; lot # 20264254.Trident 0 deg x3 insert 36e; cat # 723-00-36e; lot # p58rld.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding pain involving an 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 indicated: "i have reviewed the documentation provided for pi including the product inquiry cover sheet, and an ap pelvis x-ray and implant sheets from an index and revision surgery.The ap pelvis x-ray was pre-revision with a digital restoration modular template overlaying a primary tha.The revision implant sheet confirms revision surgery to a restoration stem and dual mobility cup occurred.No documentation was provided regarding the cause for revision was provided.Should further documentation become available i would be happy to further this investigation." 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 pain.A review of the provided medical records by a clinical consultant indicated: "i have reviewed the documentation provided for pi including the product inquiry cover sheet, and an ap pelvis x-ray and implant sheets from an index and revision surgery.The ap pelvis x-ray was pre-revision with a digital restoration modular template overlaying a primary tha.The revision implant sheet confirms revision surgery to a restoration stem and dual mobility cup occurred.No documentation was provided regarding the cause for revision was provided.Should further documentation become available i would be happy to further this investigation." 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.

• Brand Name: SIZE 4 ACCOLADE II 127 DEG
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21321849
• Report Number: 0002249697-2025-00169
• Device Sequence Number: 8129130
• Product Code: LPH
• UDI-Device Identifier: 04546540669490
• UDI-Public: 04546540669490
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2025

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 Catalogue Number: 6721-0435
• Device Lot Number: P58RLD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2024
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 94 KG