MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 44MM/-4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-044
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	04/25/2019
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.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.Device not returned.
Event or Problem Description
It was reported that the patient's right hip was revised due to the trunnion of the stem breaking off, disconnecting the stem from the head.Intra-operatively, a little black tissue was noted in the patient along with damage to the poly liner.Patient was revised to a restoration modular stem construct with a ceramic head.Rep provided a primary operative report, pre-revision x-rays, and explant pictures and reported that no further information will be available.
Event or Problem Description
It was reported that the patient's right hip was revised due to the trunnion of the stem breaking off, disconnecting the stem from the head.Intra-operatively, a little black tissue was noted in the patient along with damage to the poly liner.Patient was revised to a restoration modular stem construct with a ceramic head.Rep provided a primary operative report, pre- revision x-rays, and explant pictures and reported that no further information will be available.
Additional Manufacturer Narrative
An event regarding disassociation caused by stem trunnion fracture and metallosis/ fretting involving a lfit v40 cocr head that was mated with an accolade stem was reported.The event of crack/fracture and disassociation was confirmed by the photographs and clinician review.But the event of metallosis/ fretting was not confirmed.Method & results product evaluation and results: the reported device was not returned however photographs.Were provided for review.The photographs shows a recently explanted metal head with lot.Code k27mad on it, an accolade stem and a liner.There was blood and tissue within the head.The trunnion of the stem is fractured.Wear was noticed on the fractured trunnion tip.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: "x-rays confirms trunnion disassociation; need revision operative report, clinical and past medical history and examination of explanted components." 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 subject device has been identified to be within scope of nc and capa.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of nc and capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before (b)(6) 2011.The root cause analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.

• Brand Name: V40 COCR LFIT HEAD 44MM/-4
• 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: 8628713
• Report Number: 0002249697-2019-02029
• Device Sequence Number: 2256598
• Product Code: JDI
• UDI-Device Identifier: 07613327032710
• UDI-Public: 07613327032710
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2019

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: 01/31/2012
• Device Catalogue Number: 6260-9-044
• Device Lot Number: K27MAD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2249697-05/07/2018-003R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR