MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MERIDIAN TMZF HIP STEM #6/16MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number 6265-1-013

Device Problems Corroded (1131); Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Injury (2348); Reaction (2414); No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that hip was revised and trunnionosis was found at time of revision.All implants were replaced.

Manufacturer Narrative

An event regarding wear (trunnionosis) involving a meridian stem was reported but on the basis of mar "wear" was confirmed.A material analysis has been performed.The report concluded: "damage was observed on the stem trunnion and head taper.This damage was consistent with wear mechanisms due to the head taper and stem trunnion losing their taper lock.Burnishing, scratching and third-body indentations were observed on the insert, which is a common damage mode of uhmwpe.Yellow discoloration consistent with absorption of synovial fluid was also observed on the insert.No material or manufacturing defects were observed on the surfaces examined." no medical records or x-rays were made available for evaluation.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.There has been no other event for the lot referenced.The reported event stated that patient had a revision and trunnionosis was found.The event was confirmed as per material analysis report which indicated that damage was consistent with wear mechanisms due to the head taper and stem trunnion losing their taper lock.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.

Event Description

It was reported that hip was revised and trunnionosis was found at time of revision.All implants were replaced.

• Brand Name: MERIDIAN TMZF HIP STEM #6/16MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6648414
• MDR Text Key: 77799530
• Report Number: 0002249697-2017-01908
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972228
• 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,Followup
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2009
• Device Catalogue Number: 6265-1-013
• Device Lot Number: 11316602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2004
• 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: 51 YR
• Patient Weight: 128