MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 32MM +4 V40 TAPER VIT HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6260-5-232
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/23/2020
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
On (b)(6) 2019, it was comfirmed a armd (adverse reactions to metal debris).On (b)(6) 2020 revision surgery did.It was no tranionosis.
Event or Problem Description
2019/dec, it was comfirmed a armd (adverse reactions to metal debris).On (b)(6) 2020 revision surgery did.It was no tranionosis.
Additional Manufacturer Narrative
An event regarding fretting and corrosion involving a metal head was reported.The event was confirmed via evaluation of returned device.Method & results: product evaluation and results: damage consistent with fretting was observed on the inner taper of the head.Eds showed the head base alloy was consistent with an astm f1537 alloy; which is consistent with the drawing.The debris on the head taper was consistent an oxide, a corrosion product, biological material, and material transfer from a titanium stem.Based on the given information, no materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported the patient suffered from armd (adverse reactions to metal debris).Evaluation of the returned devices indicated that damage consistent with fretting was observed on the inner taper of the head.Eds showed the head base alloy was consistent with an astm f1537 alloy; which is consistent with the drawing.The debris on the head taper was consistent an oxide, a corrosion product, biological material, and material transfer from a titanium stem.Based on the given information, no materials or manufacturing discrepancies were observed on the surfaces examined.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 primary 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.

• Brand Name: 32MM +4 V40 TAPER VIT 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: 9746617
• Report Number: 0002249697-2020-00377
• Device Sequence Number: 13946693
• Product Code: JDI
• UDI-Device Identifier: 07613327012903
• UDI-Public: 07613327012903
• Combination Product (Y/N): N
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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: 05/31/2013
• Device Model Number: 6260-5-232
• Device Catalogue Number: 6260-5-232
• Device Lot Number: 26983503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 05/11/2020
• 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: 82 YR