MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #4; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number 6020-0435

Device Problem Metal Shedding Debris (1804)

Patient Problems Complaint, Ill-Defined (2331); Toxicity (2333)

Event Date 08/22/2014

Event Type  Injury  

Event Description

It is reported by prof.Of the hospital that there was build a massive pseudotumor 6 years after implantation (cement free hip-tep right (accolade, trident, 36er inlay).Prof.Assumed that the tumor is caused by attrition.There is a borderline amount of cobalt-ions in the blood.The customer worked with trident-pan, 52 mm e (ref unknown) with a tmzf hip-stem #4, 132° ((b)(4)/ lot 21407102).These two items will not be returned, because they are still implanted.The replaced items, which will be returned are the trident pe-inlay 0°, crossfire 36mm e ((b)(4)/ lot 21407102) and the v40 lfit head 36mm/0mm ((b)(4)/ lot n/a).

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding a massive pseudo tumor 6 years after implantation and a borderline amount of cobalt-ions in the blood involving a tmzf accolade femoral stem was reported.The event was not confirmed.Medical records received and evaluation: without adequate imaging information and histopathology report, this case cannot be solved adequately and remains just speculation.Device history review: review of the device history records indicates the devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.No further investigation for this event is possible at this time as no device and insufficient information was received by stryker orthopaedics.If devices and additional information become available, this investigation will be reopened.

Event Description

It is reported by prof.Of the hospital that there was build a massive pseudotumor 6 years after implantation (cement free hip-tep right (accolade, trident, 36er inlay).Prof.Assumed that the tumor is caused by attrition.There is a borderline amount of cobalt-ions in the blood.The customer worked with trident-pan, 52 mm e (ref unknown) with a tmzf hip-stem #4, 132 degrees (ref (b)(4) / lot 21407102).These two items will not be returned, because they are still implanted.The replaced items, which will be returned are the trident pe-inlay 0ଠcrossfire 36mm e (ref (b)(4) / lot 21407102) and the v40 lfit head 36mm/0mm (ref (b)(4) / lot n/a).

Manufacturer Narrative

An event regarding a massive pseudo tumor 6 years after implantation and a borderline amount of cobalt-ions in the blood involving a tmzf accolade femoral stem was reported.The event was confirmed.-medical records received and evaluation: review of operative notes confirms pseudo tumor.Conclusion: review of operative notes confirms pseudo tumor.In addition, a clinical consultant commented that without adequate imaging information and histopathology report, this case cannot be solved adequately and remains just speculation.No further investigation for this event is possible at this time as no device and insufficient information was received by stryker orthopaedics.If devices and additional information become available, this investigation will be reopened.

Event Description

It is reported by prof.Of the hospital that there was build a massive pseudotumor 6 years after implantation (cement free hip-tep right (accolade, trident, 36er inlay).Prof.Assumed that the tumor is caused by attrition.There is a borderline amount of cobalt-ions in the blood.The customer worked with trident-pan, 52 mm e (ref unknown) with a tmzf hip-stem #4, 132° ref 6020-0435 / lot 21407102).These two items will not be returned, because they are still implanted.The replaced items, which will be returned are the trident pe-inlay 0° crossfire 36mm e (ref 621-00-36e / lot 21407102) and the v40 lfit head 36mm/0mm (ref 6260-9-136 / lot n/a).

• Brand Name: ACCOLADE TMZF HIP STEM #4
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4093963
• MDR Text Key: 16547500
• Report Number: 0002249697-2014-03519
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K994366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2012
• Device Catalogue Number: 6020-0435
• Device Lot Number: 21407102
• Other Device ID Number: STERILE LOT# 0701XIRZA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2007
• 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): Required Intervention