MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 28/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	6570-0-128
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/10/2020
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.Device not returned.
Event or Problem Description
It was reported through the submission of a usage sheet that the patient's left hip was revised.In comparing the revision usage sheet with a previous revision usage sheet , a 28 +0 biolox head and 42e adm/ mdm insert were revised to a 28 +4 biolox head and another 42e adm/mdm insert.Update: "the patient was revised to a 28 +4 lfit head and the same 42 e liner she had in before.Reason for the revision was an inter-prosthetic dislocation.The 28 +0 biolox head that was originally implanted became disassociated from the mdm insert.There was no noticeable wear or damage to the mdm insert.The in/out implants were because the doctor decided to change the femoral head size to add more stability.He elected not to trial at first but then wanted to change the length.No explanted products are available for return per hospital policy.".

• Brand Name: DELTA V-40 CERAMIC HEAD 28/0
• 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: 9805360
• Report Number: 0002249697-2020-00479
• Device Sequence Number: 18979246
• Product Code: JDI
• UDI-Device Identifier: 04546540608499
• UDI-Public: 04546540608499
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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 Expiration Date: 01/31/2024
• Device Model Number: 6570-0-128
• Device Catalogue Number: 6570-0-128
• Device Lot Number: 69930103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/09/2020
• 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: 61 YR