MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6570-0-136
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding incorrect selection involving a metal head was reported.The event was 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: it was reported that a 36mm head was implanted with a 32mm liner.Discovery was made when patient was in the recovery room, the patient was brought back to the operating room.The provided implant sheet was reviewed and confirmed that the reported device a trident 10 deg x3 insert 32d cat#: 723-10-32d, lot#: a129j7 was implanted in the patient with a delta v-40 ceramic head 36/0 cat#: 6570-0-136, lot#: 20416252.The trident acetabular system hemispherical surgical protocol, reference number triden-sp-2_rev-5_33040 indicates: "select the appropriate corresponding v40 or c-taper femoral head size and place it onto the dry trunnion of the femoral stem with a slight twist.Impact the head with two moderate blows using the stem head impactor." the reported event is considered to be the result of user error as no manufacturing-related product problem was found given the information provided.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Primary procedure, left hip.It was reported that a 36mm biolox head was implanted with a 32d 10° liner.Discovery was made when patient was in the recovery room.Patient was brought back to the or and the femoral head was revised to a 32mm head and sleeve (the liner was not revised).Rep confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/0
• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 20628531
• Report Number: 0002249697-2024-01512
• Device Sequence Number: 15341680
• Product Code: LZO
• UDI-Device Identifier: 04546540608512
• UDI-Public: 04546540608512
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K233498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

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 Catalogue Number: 6570-0-136
• Device Lot Number: 20416252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2024
• 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: 65 YR
• Patient Sex: Female