MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	6276-1-025
Medical Device Problem Codes	Corroded (1131); Degraded (1153)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported by counsel that claimant underwent right tha on (b)(6) 2014, and was implanted with a lfit anatomic v40 femoral head.Subsequently he developed pain in his groin, lateral hip and buttocks with any motion and felt he was getting weak and getting worse.Allegedly his cobalt chrome levels were not significantly elevated but mri was concerning for possible adverse local tissue reaction.He was revised on (b)(6) 2021 for alleged trunnionosis and head/taper corrosion.
Additional Manufacturer Narrative
An event regarding corrosion, altr & wear involving a restoration modular body 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: no medical records were received for review with a clinical consultant.Product history review: could not be performed as lot code information was unknown.Complaint history review: could not be performed as lot code information was unknown.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: device name# simplex hv with gentamicin us 1 pack; cat#6195-1-001; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: 25MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-025
• 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20784923
• Report Number: 0002249697-2024-01637
• Device Sequence Number: 18393761
• Product Code: LPH
• UDI-Device Identifier: 04546540641090
• UDI-Public: 04546540641090
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K013106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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: 6276-1-025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 77 YR
• Patient Sex: Male