MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 22.2MM STD LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-122
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	04/24/2019
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.Device not returned.
Event or Problem Description
As reported: "cup, head, liners removed due to metallosis caused by malpositioned implants resulting in impingement".
Event or Problem Description
As reported: "cup, head, liners removed due to metallosis caused by malpositioned implants resulting in impingement".
Additional Manufacturer Narrative
Reported event: an event regarding metallosis caused by malpositioned implants resulting in impingement was reported.Conclusion based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event.The femoral head component in located within the adm liner component, the reported event is regarding metallosis caused by malpositioned implants resulting in impingement, the head seated within adm liner component would not have been in a position to impinge on any other device to cause the reported metallosis.The device also does not interface with the patients bone, it is fixed on the trunnion of the stem and hence, could not be malpositioned.A full investigation is completed on bone interfacing components - trident tritanium shell and unknown stem which may have been malpositioned resulting in impingement and also the metal mdm liner which may have impinged with the stem resulting in metallic fretting debris within the same complaint.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 22.2MM STD 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: 8627367
• Report Number: 0002249697-2019-02004
• Device Sequence Number: 2260334
• Product Code: JDI
• UDI-Device Identifier: 07613327013016
• UDI-Public: 07613327013016
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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: 06/30/2020
• Device Catalogue Number: 6260-9-122
• Device Lot Number: 52094401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 07/25/2019
• 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: 55 YR