MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_CERAMIC HEAD; UNKNWON CERAMIC HEAD

Catalog Number UNK_JR

Device Problems Break (1069); Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Injury (2348)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding wear of an unknown ceramic head was identified through material analysis of the explanted device.The event was confirmed through visual inspection.Method & results: device evaluation and results: analysis of the returned device was performed as part of the material analysis report (mar), dated (b)(4) 2016 , it concluded: damage was observed on the head consistent with contact against the insert fragments.A continuous metal transfer ring was observed on the proximal end of the head taper, indicating proper seating between the head taper and stem trunnion.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records and mar report by a clinical consultant concluded: a periprosthetic fracture after a fall of the patient in 2007 quite likely caused surface damage in the ceramic articulation with a wear scar contributing to progressive further damage of the ceramic surfaces with overload ending in a ¿spontaneous¿ ceramic inlay fracture in 2018 requiring revision surgery.Device 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.Conclusions: the mar concluded that damage was observed on the head consistent with contact against the insert fragments.A continuous metal transfer ring was observed on the proximal end of the head taper, indicating proper seating between the head taper and stem trunnion.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Review of the provided documentation by a clinician indicated that a periprosthetic fracture after a fall of the patient in 2007 quite likely caused surface damage in the ceramic articulation with a wear scar contributing to progressive further damage of the ceramic surfaces with overload ending in a ¿spontaneous¿ ceramic inlay fracture in 2018 requiring revision surgery.While the clinician indicates that the fracture of the device is "quite likely" as a result of periprosthetic fracture, the exact cause of the event could not be determined because insufficient information was provided.Additional information, including revision operative reports and x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

On (b)(6) 2018 extensive revision of the left hip joint with head and inlay changes.

• Brand Name: UNKNOWN_CERAMIC HEAD
• Type of Device: UNKNWON CERAMIC HEAD
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: evelyn ryan ; raheen business park; limerick NA ; 61498200
• MDR Report Key: 7975799
• MDR Text Key: 124064992
• Report Number: 0002249697-2018-03419
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR