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

Model Number	6260-9-228
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The customer reported that: "we have received a report from our operating room regarding a hip replacement reference: abg ii, batch no.: 24725908.This was removed from the patient for metallosis.The additional information we have on this prosthesis is as follows: head ref: 28mm / 4 24725908, collar ref: 5 max v40, rod ref: impossible to see.".
Additional Manufacturer Narrative
An event regarding alleged fretting involving a v40 metal head was reported.The event was confirmed on the basis of mar.Method & results: device evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated 24-feb-2020 which indicated, the head and liner were returned in the assembled condition, damage consistent with contact against the neck trunnion was observed on the inner taper of the head.Dimensional inspection: not performed as device was returned in damage state.Functional inspection: not performed as device was returned in damage state.Material analysis: a material analysis has been performed.The report concluded: energy-dispersive spectroscopy was performed on stem, neck, and collected debris.Biological material was observed on the porous region of the stem.Damage consistent with contact against the neck trunnion was observed on the inner taper of the head.Burnishing, scratching, and third body indentations were observed on the outer articulating surface of the liner; these are common damage modes of uhmwpe.The neck and stem base metal were consistent with astm f1537 and astm f1813 materials.The collected debris was consistent with an oxide, a corrosion product, biological material, and the base material of the neck and stem.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical review was provided for clinician review.Device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the root cause cannot be established as insufficient information was received.Further information such as operative reports, x-rays, histopathology reports, patient history & follow-up notes are needed to investigate this event further.If additional information become available, this investigation will be reopened.
Event or Problem Description
The customer reported that : "we have received a report from our operating room regarding a hip replacement.Reference: abg ii, batch no.: 24725908.This was removed from the patient for metallosis.The additional information we have on this prosthesis is as follows: head ref: 28mm / 4 24725908, collar ref: 5 max v40, rod ref: impossible to see ".

• Brand Name: 28MM +4 LFIT V40 HEAD
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9547802
• Report Number: 0002249697-2020-00025
• Device Sequence Number: 16727981
• Product Code: JDI
• UDI-Device Identifier: 07613327013061
• UDI-Public: 07613327013061
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K022077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

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: 08/31/2014
• Device Model Number: 6260-9-228
• Device Catalogue Number: 6260-9-228
• Device Lot Number: 24725908R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 97