MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DELTA V-40 CERAMIC HEAD 36/+7,5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6570-0-736
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left hip was revised after patient complaint of pain.Intra-operatively, the following was noted: the ceramic head was broken into at least 2 pieces.The inside of the head showed concentric wear, and the trunnion was damaged.Revising surgeon reported his assessment: the surgeon for the index procedure (different surgeon) wasted a -5 ceramic head, and implanted a +7.5 ceramic head without a sleeve.Revising surgeon believes the head was not fully impacted on the stem, leading to motion of the head on the stem.The ceramic head and neutral poly liner were revised to another ceramic head and neutral ecentric poly liner (reason for the liner change was the surgeon wanted to tighten up the construct and did not want to use a +7.5 or +10 head).
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
It was reported that the patient's left hip was revised after patient complaint of pain.Intra-operatively, the following was noted: the ceramic head was broken into at least 2 pieces.The inside of the head showed concentric wear, and the trunnion was damaged.Revising surgeon reported his assessment: the surgeon for the index procedure (different surgeon) wasted a -5 ceramic head, and implanted a +7.5 ceramic head without a sleeve.Revising surgeon believes the head was not fully impacted on the stem, leading to motion of the head on the stem.The ceramic head and neutral poly liner were revised to another ceramic head and neutral ecentric poly liner (reason for the liner change was the surgeon wanted to tighten up the construct and did not want to use a +7.5 or +10 head).
Additional Manufacturer Narrative
An event regarding crack/fracture involving a ceramic head was reported.The event was confirmed.Method & results: product evaluation and results: the device was not returned; however, a photograph was provided for review.The photograph shows that the ceramic head has fractured down the midline approximately in half.Two additional smaller fragments of the ceramic head are also visible.The device fragments appear covered in blood.Clinician review: a review with a clinical consultant indicated "the photographs show a biolox dela ceramic head that has fractured in to 2 pieces.Similarly, thx-ray shows a press fit tha stem with a head that has fractured and displaced.Fracture of a biolox delta head is confirmed.Per the event description the root cause of the fractured head was related to the index surgeon "wasted a -5 ceramic head, and implanted a +7.5-ceramic head without a sleeve.".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 device was not returned; however, a photograph was provided for review.The photograph shows that the ceramic head has fractured down the midline approximately in half.Two additional smaller fragments of the ceramic head are also visible.The device fragments appear covered in blood.A review with a clinical consultant indicated "the photographs show a biolox dela ceramic head that has fractured in to 2 pieces.Similarly, thx-ray shows a press fit tha stem with a head that has fractured and displaced.Fracture of a biolox delta head is confirmed.Per the event description the root cause of the fractured head was related to the index surgeon "wasted a -5 ceramic head, and implanted a +7.5-ceramic head without a sleeve." 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.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/+7,5
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19517455
• Report Number: 0002249697-2024-00869
• Device Sequence Number: 6031230
• Product Code: LZO
• UDI-Device Identifier: 04546540608581
• UDI-Public: 04546540608581
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K052718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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: 6570-0-736
• Device Lot Number: 98921704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2023
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 132 KG