MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 28MM +4 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6260-5-228

Device Problems Corroded (1131); Material Erosion (1214)

Patient Problems Metal Related Pathology (4530); Insufficient Information (4580)

Event Date 07/14/2022

Event Type  Injury  

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.

Event 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".

Manufacturer Narrative

Reported event: an event regarding corrosion/metallosis and abnormal ion level involving a metal head 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 inside the head taper.The device also has minor damage 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.Correction: manufacturing site(g1).

Event 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: 28MM +4 V40 TAPER VIT HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15154200
• MDR Text Key: 297138116
• Report Number: 0002249697-2022-01135
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327012897
• UDI-Public: 07613327012897
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 6260-5-228
• Device Catalogue Number: 6260-5-228
• Device Lot Number: 41936002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention