MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/-2,5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6570-0-436
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Discomfort (2330)
Date of Event	06/21/2023
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.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.H3 other text : device not returned to the manufacturer.
Event or Problem Description
Patient had a left hip revision due to post operative discomfort.Investigative revision performed to determine infection, no active infection during this process, determined reason for revision was metallosis.
Additional Manufacturer Narrative
Correction: investigation conclusion reveals that this reported device is not a suspected cause or contributor to the patient's experience and considered concomitant.
Event or Problem Description
Patient had a left hip revision due to post operative discomfort.Investigative revision performed to determine infection, no active infection during this process, determined reason for revision was metallosis.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/-2,5
• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17649299
• Report Number: 0002249697-2023-00970
• Device Sequence Number: 20652663
• Product Code: LZO
• UDI-Device Identifier: 04546540608567
• UDI-Public: 04546540608567
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K052718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 08/31/2026
• Device Catalogue Number: 6570-0-436
• Device Lot Number: 88045705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female