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

Catalog Number	6260-9-232
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	05/20/2019
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
As reported: "patient experienced pain in back/ hip around (b)(6) 2018.In subsequent visits a fluid/ tissue mass was seen on imaging.Revision surgery was performed on (b)(6) 2019.Original surgery was in 2009.Dark fluid and tissue was seen in joint.Stem was removed and replaced with a long cemented stem, cup was retained".
Event or Problem Description
As reported: "patient experienced pain in back/ hip around (b)(6) 2018.In subsequent visits a fluid/ tissue mass was seen on imaging.Revision surgery was performed on (b)(6) 2019.Original surgery was in 2009.Dark fluid and tissue was seen in joint.Stem was removed and replaced with a long cemented stem, cup was retained".
Additional Manufacturer Narrative
An event regarding corrosion and disassociation involving a metal head was reported.The event was confirmed by material analysis.Method & results product evaluation and results: visual inspection of the returned device was performed as part of material analysis report dated (b)(6)2019.The inspection noted the following: damage present on the surface of the taper is consistent with interaction between the head and trunnion.Material analysis of the returned device noted the following: the damage on the neck and trunnion of the hip stem was consistent with loss of taper lock.Eds showed each metallic device was consistent with the drawing and the debris on the head and liner was consistent with material transfer from the stem.Based on the given information, no identifiable 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: 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 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: 8697204
• Report Number: 0002249697-2019-02247
• Device Sequence Number: 2600774
• Product Code: JDI
• UDI-Device Identifier: 07613327013085
• UDI-Public: 07613327013085
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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: 02/28/2013
• Device Catalogue Number: 6260-9-232
• Device Lot Number: 29179901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 09/19/2019
• 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