MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 28MM, +0MM NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU

Catalog Number	6565-0-128
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/09/2018
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 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
The surgeon revised a failed exeter / contemporary cup.The surgeon reported a shattered femoral head and a very worn femoral trunnion.Update- one year follow up x-ray showed a ceramic head fracture.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a ceramic head was reported.The event was confirmed through review of the provided x-rays by a clinical consultant.Method & results: device evaluation and results: visual inspection: the reported device was not returned however photographs were provided for review.The photographs shows a recently explanted ceramic head with.From the photographs provided there is evidence that the device is fractured.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided x-rays by a clinical consultant indicated: x-rays confirm the ceramic head fracture with substantial secondary damage to the trunnion.Component position is very adequate including the cup.Bone grafting had been performed for a central protrusion but the result was excellent regarding anatomic reconstruction and as such plays no role in the failure scenario.Also otherwise no indications or evidence for an overload condition potentially contributing to the event.Cup malposition frequently plays a role in this type of failure but apparently does not apply to this case.As such can unfortunately no exact cause of failure be established based upon current information.High activity level of the patient is not usually a cause of ceramic head fracture with poly cup bearings.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
The surgeon revised a failed exeter / contemporary cup.The surgeon reported a shattered femoral head and a very worn femoral trunnion.Update: one year follow up x-ray showed a ceramic head fracture.

• Brand Name: ALUMINA V40-FEMORAL HEAD 28MM, +0MM NK
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROU
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7615744
• Report Number: 0002249697-2018-01878
• Device Sequence Number: 11333191
• Product Code: LZO
• UDI-Device Identifier: 04546540390462
• UDI-Public: 04546540390462
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K023901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

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: 07/31/2020
• Device Catalogue Number: 6565-0-128
• Device Lot Number: 52652903
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 09/12/2018
• 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: 68 YR