MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 25MM DEEP MILLED BODY COMPONENT 9002-0-5571; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6276-5-016
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214)
Health Effect - Clinical Codes	Metal Related Pathology (4530); Insufficient Information (4580)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been reported "a revision surgery was required due to "raised metal ion levels".Surgeon reported signs of metallosis at the femoral head/taper implant junction.The surgeon decided the best thing for the patient was to remove the milled body and replace it with the same sized one and put a ceramic head on".
Additional Manufacturer Narrative
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 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.
Additional Manufacturer Narrative
Reported event: an event regarding corrosion/metallosis and abnormal ion level involving a restoration modular body was reported.The corrosion event was confirmed via evaluation of the returned device.Abnormal ion level was not confirmed.Method & results: -product evaluation and results: -visual inspection: visual inspection of the returned device indicated that a black debris is observed on the trunnion.The device has minor damage and bony residue consistent with explantation.-material analysis: a material analysis of the returned device was performed and concluded the following: "review of the milled body component and v40 head was completed for evidence of metallosis.Characterisation using stereo microscopy confirmed material wear of the stem trunnion and within the head taper.Energy dispersive spectroscopy confirmed oxidation of both components in the discoloured regions, indicating corrosion.No manufacturing related defects were observed on the examined areas of the components." -clinician review: no medical records were received for review with a clinical consultant.-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 elevated metal ions and corrosion at the stem-head junction.A material analysis of the returned devices was performed and concluded the following: "review of the milled body component and v40 head was completed for evidence of metallosis.Characterisation using stereo microscopy confirmed material wear of the stem trunnion and within the head taper.Energy dispersive spectroscopy confirmed oxidation of both components in the discoloured regions, indicating corrosion.No manufacturing related defects were observed on the examined areas of the components." the elevated metal ions could not be confirmed without medical records.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.
Event or Problem Description
It has been reported "a revision surgery was required due to "raised metal ion levels".Surgeon reported signs of metallosis at the femoral head/taper implant junction.The surgeon decided the best thing for the patient was to remove the milled body and replace it with the same sized one and put a ceramic head on".

• Brand Name: 25MM DEEP MILLED BODY COMPONENT 9002-0-5571
• 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: arokiya raj ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15154197
• Report Number: 0002249697-2022-01136
• Device Sequence Number: 5268034
• Product Code: LPH
• UDI-Device Identifier: 07613153071389
• UDI-Public: 07613153071389
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K013106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

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: 12/31/2015
• Device Model Number: 6276-5-016
• Device Catalogue Number: 6276-2-125
• Device Lot Number: T92118B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2010
• 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 Sex: Unknown