MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 32MM, -4MM NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6565-0-032
Medical Device Problem Codes	Component Incompatible (1108); Mechanical Problem (1384)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/29/2019
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 similar 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 v40 femoral head was very loose after installed.Finally, the surgeon used 32+0mm femoral head to finish medical procedure.
Additional Manufacturer Narrative
An event regarding size/fit issue involving a ceramic head was reported.The event was not confirmed.Method & results: device evaluation and results: the head was returned for evaluation, black marks are visible on the outer surface and inner taper of the head.Clinician review: no medical records were received for review with a clinical consultant.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: an event regarding size/fit issue involving a ceramic head was reported.The event cannot be confirmed as insufficient information was provided.The head was returned for evaluation, black marks are visible on the outer surface and inner taper of the head consistence with attempted implantation and explantation damage.Further information such as images /video of the device taken when the event occurred as well as primary operative reports are required to confirm the event and determine a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
The v40 femoral head was very loose after installed.Finally, the surgeon used 32+0mm femoral head to finish medical procedure.Update: the complaint issue result in patient's leg length discrepancy.

• Brand Name: ALUMINA V40-FEMORAL HEAD 32MM, -4MM NK
• 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: 9278433
• Report Number: 0002249697-2019-03686
• Device Sequence Number: 11360006
• Product Code: JDI
• UDI-Device Identifier: 04546540390479
• UDI-Public: 04546540390479
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 6565-0-032
• Device Lot Number: 52441103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 01/08/2020
• 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: Other