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

Catalog Number	6260-9-144
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported relevant discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, 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 (b)(6) 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
Surgeon revised a stem, head and liner due to trunnionosis.Original surgery was (b)(6) 2007.Update 23/august/2018: rep provided explant pictures, pre-revision x-rays, primary operative report, and usage sheets from primary and revision procedures.Explant picture shows wear on the rim of the poly insert and pre-revision x-rays show the head disassociated from the stem.
Event or Problem Description
Surgeon revised a stem, head and liner due to trunnionosis.Original surgery was (b)(6) 2007.Update (b)(6) 2018: rep provided explant pictures, pre-revision x-rays, primary operative report, and usage sheets from primary and revision procedures.Explant picture shows wear on the rim of the poly insert and pre-revision x-rays show the head disassociated from the stem.
Additional Manufacturer Narrative
An event regarding disassociation involving an accolade stem was reported.The event was confirmed on review of the provided medical records by a clinical consultant.Method & results: device evaluation and results: a review of the provided photo of the explanted head showed nothing remarkable.Medical records received and evaluation a review of the provided medical records by a clinical physician noted; review of these records confirms femoral head dissociation from a tha femoral stem occurred secondary to remodeling and loss of material of the femoral stem trunnion.The root cause cannot be determined as insufficient information was available device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: review indicated there have been no other similar events for the reported lot.Conclusion: the event was confirmed on review of the provided medical records by a clinical physician however the root cause could not be determined.It is noted that the subject device has been identified to be within scope of an nc and capa.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of the 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/+0
• 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: 7883074
• Report Number: 0002249697-2018-02908
• Device Sequence Number: 19459780
• Product Code: JDI
• UDI-Device Identifier: 07613327032734
• UDI-Public: 07613327032734
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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: 08/31/2012
• Device Catalogue Number: 6260-9-144
• Device Lot Number: DHTMLD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 10/24/2018
• 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: 2249697-05-07-2018-003R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR