MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 28MM, -2.7MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	6565-0-028
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	03/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that he will be undertaking a revision of an exeter/ 32mm alumina femoral head with trident x3 poly in a (b)(6) female of (b)(6) weight.The primary was done in (b)(6) 2016.The patient has been to clinic and the x-ray showed the femoral head has fractured.The customer further reported that there was nothing unusual about the primary surgery.
Additional Manufacturer Narrative
An event regarding crack/fracture involving an ceramic head was reported.The event was confirmed.Method & results: device evaluation and results: the material analysis report concluded: " the ceramic head was fractured.The location of the fracture origin could not be determined due to secondary chipping on the fracture surfaces.The trunnion, neck, and shoulder areas of the stem contained abrasion damage throughout their surfaces, consistent with contact with a hard object.The liner contained abrasion damage on the articulating surface and distal rim, consistent with contact with the stem.Direct contact between the stem and liner was enabled when the head fractured off the trunnion.No material or manufacturing defects were observed on the device features examined ".A functional and dimensional inspection was not performed based on the nature of the reported event medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar event for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pre- and post-op xrays, patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
The customer reported that he will be undertaking a revision of an exeter/ 32mm alumina femoral head with trident x3 poly in a 65 year old female of 80kg¿s weight.The primary was done in (b)(6) 2016.The patient has been to clinic and the x-ray showed the femoral head has fractured.The customer further reported that there was nothing unusual about the primary surgery.

• Brand Name: ALUMINA V40-FEMORAL HEAD 28MM, -2.7MM
• 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: 6485884
• Report Number: 0002249697-2017-01220
• Device Sequence Number: 19113301
• Product Code: LZO
• UDI-Device Identifier: 04546540402127
• UDI-Public: (01)04546540402127(11)160330(17)210331(10)55260103
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 6565-0-028
• Device Catalogue Number: 6565-0-028
• Device Lot Number: 55260103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 11/06/2017
• 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: 65 YR
• Patient Weight: 80