MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 36MM, -5MM NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	6565-0-036
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, an adverse event occurred during the implantation of the ceramic alumina head ref: (b)(4), sn:(b)(6).While adjusting the hip joint and checking the proper rotation of the joint ( abduction, adduction of the hip joint), the alumina head that had already been implanted on the accolade ii stem broke.Since the same head ( alumina in size 36) was available at the stryker implant commissary in the operating theater, the procedure was completed without a problem and at the right time.
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.H3 other text : not returned.
Event or Problem Description
On january 29, 2024, an adverse event occurred during the implantation of the ceramic alumina head ref: 6565-0-036, sn:(b)(6).While adjusting the hip joint and checking the proper rotation of the joint ( abduction, adduction of the hip joint), the alumina head that had already been implanted on the accolade ii stem broke.Since the same head ( alumina in size 36) was available at the stryker implant commissary in the operating theater, the procedure was completed without a problem and at the right time.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a ceramic head was reported.The event was confirmed via provided photographs of the device.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: 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 the ceramic head fractured during surgery.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.Further information such as return of the device is needed to complete the investigation for determining root cause.It should be noted that the ifu packaged with the device indicates the following: "use caution when handling ceramic components during assembly because of the brittle nature of ceramic material." 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: ALUMINA V40-FEMORAL HEAD 36MM, -5MM NK
• 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: 18785513
• Report Number: 0002249697-2024-00299
• Device Sequence Number: 8333519
• Product Code: LZO
• UDI-Device Identifier: 04546540402141
• UDI-Public: 04546540402141
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K023901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6565-0-036
• Device Lot Number: 13819252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2023
• 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: Other
• Patient Sex: Unknown