MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 44MM/+0; HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	6260-9-144
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Edema (1820); Inflammation (1932); Necrosis (1971); Pain (1994); Injury (2348); Reaction (2414)
Date of Event	12/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.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.Not returned.
Event or Problem Description
The customer reported in his letter to stryker (b)(4) that he underwent an emergency revision of his accolade / lfit v40 right hip replacement at the (b)(6) hospital, (b)(6) on the (b)(6) 2017 following extreme pain.Supplementary documentation provided by the patient states that during the revision, the surgeon, mr (b)(6) found extensive metallosis from a worn trunnion that was grinding into the bone anterosuperiorly to the socket, a dark grey fluid within the joint, pockets of pseudotumour, bone necrosis and significant muscle damage around the hip.Enclosed njr records show that the primary operation was completed on (b)(6) 2009 at (b)(6) centre by mr (b)(6), and that the patient was revised to a restoration modular conical distal stem, restoration modular cone body, v40 delta ceramic head and a trident constrained liner.The enclosed operation notes state that the patient suffered a greater trochanter fracture during the revision which was fixated with a large dall miles hook plate, 2 x dall miles cables and x 2 large fragment screws.
Event or Problem Description
The customer reported in his letter to stryker uk that he underwent an emergency revision of his accolade / lfit v40 right hip replacement at the princess royal hospital, haywards heath on the (b)(6) 2017 following extreme pain.Supplementary documentation provided by the patient states that during the revision, the surgeon, mr ps, found extensive metallosis from a worn trunnion that was grinding into the bone anterosuperiorly to the socket, a dark grey fluid within the joint, pockets of pseudotumour, bone necrosis and significant muscle damage around the hip.Enclosed njr records show that the primary operation was completed on 3rd october 2009 at the sussex orthopedic nhs treatment centre by mr tm, and that the patient was revised to a restoration modular conical distal stem, restoration modular cone body, v40 delta ceramic head and a trident constrained liner.The enclosed operation notes state that the patient suffered a greater trochanter fracture during the revision which was fixated with a large dall miles hook plate, 2 x dall miles cables and x 2 large fragment screws.
Additional Manufacturer Narrative
An event regarding wear involving an metal head was reported.The event was confirmed by medical review.Method & results: -product evaluation and results: not performed as no products were returned.-clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: " the patient underwent a primary press-fit tha on october 3, 2009.This hip reportedly went on to failure due to wear between the femoral head and the trunnion and required revision.The operative findings revision surgery included extensive metallosis from worn trunnion.The trunnion was found to be grinding into the bone anterosuperiorly above the acetabulum.Proximal 150mm dark grey fluid was found within the joint.Significant muscle necrosis of the obturator piriformis and gluteus minimus and partial necrosis of the gluteus medius was observed.The components themselves were well fixed however necrosis of the bone from the socket and trochanteric portion of the femure was identified.During the revision procedure thorough debridement and removal of necrotic tissue was carried out.The accolade stem was carefully removed with flexible osteotomes however an inadvertent fracture trochanter occurred requiring internal fixation with a dall-miles hook plate and cables." -product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the event of wear was confirmed based on the provided medical review.Review of the provided medical review revealed that "review of these records confirms a revision tha for "wear between the head and trunnion" occurred, along with metallosis and soft tissue bone destruction however, the root cause cannot be determined as insufficient information was available" further information such as implant retrieval with material analysis, operative reports, dated pre and post op x-rays/ imaging from the index and revision surgeries, outpatient office/clinic notes and surgical pathology reports are needed to complete the investigation for determining root cause.The subject device has been identified to be within scope of a recall.Lot specific voluntary recall was initiated for the lfit v40 cocr heads.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 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 for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: V40 COCR LFIT HEAD 44MM/+0
• Common Device Name: HIP JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7616959
• Report Number: 0002249697-2018-01893
• Device Sequence Number: 1555296
• Product Code: JDI
• UDI-Device Identifier: 07613327032734
• UDI-Public: 07613327032734
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: 02/28/2014
• Device Catalogue Number: 6260-9-144
• Device Lot Number: MHA5R2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 08/22/2018
• 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: 2249697-05-07-2018-003-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 77 YR