MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 0580-1-441

Device Problems Material Discolored (1170); Material Deformation (2976)

Patient Problem Injury (2348)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported that the patient was revised following the fracture of a ceramic head.Update: upon device return on (b)(6) 2018, damage to the trunnion of the stem was noted.

Manufacturer Narrative

An event regarding a wear involving an exeter stem was reported.The event was confirmed following material analysis.Method & results: visual inspection: visual inspection: visual inspection was performed as part of the material analysis report (mar), dated (b)(6)2018.Images of the device are included in the mar.The parts were examined with the aid of a stereo microscope at magnifications up to 50x.The anterior, posterior, superior and inferior surfaces of the stem, respectively.Damages were observed on all surfaces of the neck and trunnion of the stem.Damage consistent with the explantation process was also observed on the stem.The fracturing of the ceramic head likely allowed the stem, insert and head fragments to articulate against each other.This articulation of the three devices against each other likely caused the damage and discoloration observed.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.A continuous metal transfer ring was not observed at the proximal end of the head taper.Damage was observed on the stem, 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.-device evaluation and results: -medical records received and evaluation: a medical review was not performed because no medical information was provided.-device history review: not performed as the reported lot# is unknown.-complaint history review: not performed as the reported lot# is unknown conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including device lot number, operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.

Event Description

The customer reported that the patient was revised following the fracture of a ceramic head.Update: upon device return on (b)(6)2018, damage to the trunnion of the stem was noted.

• Brand Name: EXETER V40 STEM 44MM NO 1
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7433414
• MDR Text Key: 105572602
• Report Number: 0002249697-2018-01133
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0580-1-441
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention