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

Catalog Number	6570-0-236
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient had a 3 foot fall.Ceramic head was smashed in pieces and required a new femoral head with dual mobility.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a ceramic head was reported.The event was confirmed by returned of the device and clinician review of the provided x-ray.Method & results: product evaluation and results: the device was returned fractured with metal marking visible on the fractured portions of the head.A review of the returned device by a material analysis engineer indicates: metal transfer markings and secondary chipping were observed on the head fragments; obscuring the fracture surfaces.The general fracture direction is outward and longitudinal.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.The overload fracture morphology is consistent with the reported event.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: a review of the provided medical records was rejected by a clinical consultant stated the following comment: undated provided x-ray confirms ceramic head fracture, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: the device was returned fractured with metal marking visible on the fractured portions of the head.A review of the returned device by a material analysis engineer indicates: metal transfer markings and secondary chipping were observed on the head fragments; obscuring the fracture surfaces.The general fracture direction is outward and longitudinal.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.The overload fracture morphology is consistent with the reported event.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.A review of the provided medical records confirms ceramic head fracture, the exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as primary and revision operative reports, clinical and past medical history, additional serial dated x-rays are required to complete the investigation and determine a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient had a 3 foot fall.Ceramic head was smashed in pieces and required a new femoral head with dual mobility.

• Brand Name: DELTA V-40 CERAMIC HEAD 36/+5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9109106
• Report Number: 0002249697-2019-03302
• Device Sequence Number: 1984003
• Product Code: JDI
• UDI-Device Identifier: 04546540608543
• UDI-Public: 04546540608543
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

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: 05/31/2006
• Device Catalogue Number: 6570-0-236
• Device Lot Number: 66628601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 11/21/2019
• 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: 70 YR
• Patient Weight: 91