MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 0580-1-442

Device Problems Fracture (1260); Deformation Due to Compressive Stress (2889)

Patient Problem Injury (2348)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that an alleged broken ceramic head and liner was retrieved from a patient.

Manufacturer Narrative

An event regarding damage involving an exeter stem was reported.The event was confirmed through material analysis of the returned device.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated (b)(6) 2019.This inspection indicated: the anterior, posterior, superior, and inferior views of the stem are shown respectively.Damage consistent with the implantation/explantation process was observed on the anterior and posterior surfaces of the stem.Debris was observed on the anterior, posterior, and inferior surfaces and was further analyzed with a sem.Damage was observed on the inferior surface of the neck and main body of the stem consistent with contact against the titanium sleeve.Damage was also observed on the trunnion consistent with contact against the alumina insert.This inspection indicated a material analysis has been performed.The report concluded: the alumina head was returned fractured in pieces and no evidence of a continuous metal transfer ring was observed.Impingement from the stem and damage consistent with contact against a hard object was observed on the distal rim of the titanium sleeve.Edge cracking was observed on the alumina insert due to contact against the stem in addition to metal transfer markings.Damage consistent with the implantation/explantation process was observed on the anterior and posterior surfaces of the stem.Damage consistent with impingement on the shell was observed on the inferior surface of the stem.Debris was also observed on the anterior, posterior, and inferior surfaces of the stem and elemental analysis confirmed it to be consistent with an oxide, base material, biological material and the decontamination process.Debris was observed on the proximal surface of the shell and elemental analysis confirmed it to be consistent with an oxide, biological material, the base material, and an unknown material.Elemental analysis confirmed that the shell and stem are consistent with an astm f136 alloy and an astm f1586 alloy, respectively.Based on the given information, no identifiable material 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: indicated all 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.Conclusion: the material analysis report concluded.The alumina head was returned fractured in pieces and no evidence of a continuous metal transfer ring was observed.Impingement from the stem and damage consistent with contact against a hard object was observed on the distal rim of the titanium sleeve.Edge cracking was observed on the alumina insert due to contact against the stem in addition to metal transfer markings.Damage consistent with the implantation/explantation process was observed on the anterior and posterior surfaces of the stem.Damage consistent with impingement on the shell was observed on the inferior surface of the stem.Debris was also observed on the anterior, posterior, and inferior surfaces of the stem and elemental analysis confirmed it to be consistent with an oxide, base material, biological material and the decontamination process.Debris was observed on the proximal surface of the shell and elemental analysis confirmed it to be consistent with an oxide, biological material, the base material, and an unknown material.Elemental analysis confirmed that the shell and stem are consistent with an astm f136 alloy and an astm f1586 alloy, respectively.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as pre- and post-operative x-rays and the primary 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that an alleged broken ceramic head and liner was retrieved from a patient.

• Brand Name: EXETER V40 STEM 44MM NO 2
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9335728
• MDR Text Key: 166975283
• Report Number: 0002249697-2019-03802
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 04546540153319
• UDI-Public: 04546540153319
• Combination Product (y/n): N
• PMA/PMN Number: K173499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 0580-1-442
• Device Lot Number: G3992796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention