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

Model Number	6570-0-232
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event an event regarding user error incorrectly sized implant involving a ceramic head was reported.The event was not confirmed.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
That after performing the final trial with a 28 mm 4 mm head and deciding the implant, sr accidentally opened the 32 mm 4 mm implant.After the procedure, x-ray revealed that the inner diameter of the cup and the diameter of the head did not match.So 32 mm 4 mm was revised to 28 mm 4 mm.Update: the primary implantation took place the same day as the revision.The patient was not taken off of anesthesia and then put back under anesthesia.

• Brand Name: DELTA V-40 CERAMIC HEAD 32/+4
• 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: 11495908
• Report Number: 0002249697-2021-00472
• Device Sequence Number: 16861449
• Product Code: LZO
• 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 Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2021

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: 09/30/2023
• Device Model Number: 6570-0-232
• Device Catalogue Number: 6570-0-232
• Device Lot Number: LHR414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 03/16/2021
• 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