MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 36MM, +0MM NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6565-0-136
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
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
"the patient had pain and mobility difficulties." "the implant broke inside the patient.A surgical re-approach was performed, changing the head and insert.".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a ceramic head was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device was performed as part of the material analysis: "images depicted show the returned pieces of the alumina v40 femoral head and the trident insert.On visual examination, fracture of the femoral head was observed with eleven pieces returned.The pieces showed a generally longitudinal fracture pattern.This type of pattern is created by hoop stress through the wedge effect of the stem trunnion." material analysis: a material analysis was performed on the returned device which concluded the following: "review of alumina v40 femoral head 36 +0mm, catalogue # 6565-0-136, lot code 62297703 confirmed fracture.Characterisation using stereo microscopy confirmed the femoral head fractured in overload.No manufacturing or material related defects were observed on the device surfaces examined." 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 patient was revised due to a broken implant.The broken ceramic head was returned for evaluation.Material analysis of the returned device indicated the following: "on visual examination, fracture of the femoral head was observed with eleven pieces returned.The pieces showed a generally longitudinal fracture pattern.This type of pattern is created by hoop stress through the wedge effect of the stem trunnion.[.] review of alumina v40 femoral head 36 +0mm, catalogue # 6565-0-136, lot code 62297703 confirmed fracture.Characterisation using stereo microscopy confirmed the femoral head fractured in overload.No manufacturing or material related defects were observed on the device surfaces examined." further information such as pathology reports, pre- and post-operative x-rays, and the revision 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
"the patient had pain and mobility difficulties." "the implant broke inside the patient.A surgical re-approach was performed, changing the head and insert.".

• Brand Name: ALUMINA V40-FEMORAL HEAD 36MM, +0MM NK
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 18136314
• Report Number: 0002249697-2023-01405
• Device Sequence Number: 12402039
• Product Code: JDI
• UDI-Device Identifier: 04546540390486
• UDI-Public: 04546540390486
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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 Expiration Date: 11/30/2022
• Device Catalogue Number: 6565-0-136
• Device Lot Number: 62297703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2017
• 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 Sex: Unknown