MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA C-TAPER HEAD 32MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	17-3205E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Injury (2348)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Device not returned.
Event or Problem Description
Patient fell playing lawn bowls last thursday and continued playing after fall.On sunday, patient was walking and heard a crack.Ceramic head fractured resulting in revision surgeon with replacement sleeve and head implanted.Surgeon today performed revision hip surgery.A sleeve and head were implanted.Original ceramic liner left in situ.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a ceramic head was reported.The event was confirmed by visual inspection and medical review.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.From the photographs provided there is evidence that the device is fractured.This can be seen both intraoperatively and once the device is explanted.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: provided x-ray & surgery images confirm fractured alumina head, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.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: a review of the provided medical records by a clinical consultant stated the following comment: provided x-ray & surgery images confirm fractured alumina head.The exact cause of the event could not be determined because insufficient information was provided.Additional information including primary and revision operative reports, clinical and past medical history and additional serial dated x-rays 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
Patient fell playing lawn bowls last thursday and continued playing after fall.On sunday, patient was walking and heard a crack.Ceramic head fractured resulting in revision surgeon with replacement sleeve and head implanted.Surgeon today performed revision hip surgery.Picture intra op is attached.A sleeve and head were implanted.Original ceramic liner left in situ.

• Brand Name: ALUMINA C-TAPER HEAD 32MM/+5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9566692
• Report Number: 0002249697-2020-00053
• Device Sequence Number: 14260328
• Product Code: LZO
• UDI-Device Identifier: 07613327101188
• UDI-Public: 07613327101188
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K971409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/27/2020

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 Model Number: 17-3205E
• Device Catalogue Number: 17-3205E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 02/27/2020
• 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: 70 YR