MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA V40-FEMORAL HEAD 32MM, -4MM NK; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6565-0-032
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Broken ceramic cup updated event as per sales rep: this was revision due the fact that the ceramic head was broken.
Event or Problem Description
Broken ceramic cup.Updated event as per sales rep: this was revision due the fact that the ceramic head was broken.
Additional Manufacturer Narrative
Correction to explant date.Reported event: an event regarding crack/fracture involving a ceramic head.The event was confirmed by inspection.Method & results: -product evaluation and results: visual inspection: visual inspection was performed as part of the material analysis report (mar).This inspection indicated the returned devices are shown.The device was examined with the aid of a stereo microscope at magnifications up to 50x.The fractured pieces of the head were labeled a-d for clarity.The returned, fractured ceramic head is shown.Metal transfer markings and secondary chipping were observed on the head fragments.The fracture surfaces were damaged by post-fracture chipping which obscured the fracture surfaces.The general fracture morphology is consistent with a longitudinal fracture.This type of longitudinal fracture pattern is created by overload hoop stresses caused by the wedge effect of the stem trunnion.A continuous metal transfer ring was not observed at the proximal end of the head taper.The observation of a continuous metal transfer ring at the proximal end of the head taper is consistent with proper seating between the head taper and stem trunnion.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Material analysis: a material analysis has been performed.The report concluded: the returned ceramic head had fractured.The head likely fractured due to hoop stresses caused by the edge effect.Damage was observed on the insert and head fragments consistent with articulating against each other after the head fractured.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-clinician review: no medical records were received for review with a clinical consultant.-product history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: it was reported that ceramic head was broken.The event was confirmed by inspection.The exact cause of the event could not be determined because insufficient information was provided.Additional information including device lot id, operative reports, progress notes and x-rays are needed to fully investigate the event.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ALUMINA V40-FEMORAL HEAD 32MM, -4MM NK
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 11575388
• Report Number: 0002249697-2021-00550
• Device Sequence Number: 19738507
• Product Code: LPH
• UDI-Device Identifier: 04546540402134
• UDI-Public: 04546540402134
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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 Model Number: 6565-0-032
• Device Catalogue Number: 6565-0-032
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 10/28/2021
• 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
• Patient Age: 51 YR
• Patient Weight: 90