MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 32/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6570-0-232
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/09/2021
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
Revision due to infection.Delta ceramic head was revised to new one.Sleeve or metal head should be used.Surgeon decided to just follow-up if there are no complications in the near future.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a ceramic head was reported.The event was not confirmed.Method & results: device evaluation and results: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot and sterile lot.Conclusions: it was reported that the patient's hip was revised due to infection.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.Further information such as return of device, pre- and post-op x- rays, patient history, pathology report & follow-up notes are needed to investigate this event further.All stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance to applicable iso standards.If additional information and/or device becomes available, this investigation will be reopened.
Event or Problem Description
Revision due to infection.Delta ceramic head was revised to new one.Sleeve or metal head should be used.Surgeon decided to just follow-up if there are no complications in the near future.

• Brand Name: DELTA V-40 CERAMIC HEAD 32/+4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 11946392
• Report Number: 0002249697-2021-00973
• Device Sequence Number: 1085956
• Product Code: JDI
• UDI-Device Identifier: 04546540608536
• UDI-Public: 04546540608536
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

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: 01/31/2026
• Device Model Number: 6570-0-232
• Device Catalogue Number: 6570-0-232
• Device Lot Number: 83153102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male