MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 28MM/+10; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Catalog Number 06-2810

Device Problems Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Injury (2348); No Code Available (3191)

Event Date 06/29/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2008, the revision from the bipolar to tha was performed.The cup and the liner are products of other companies.On (b)(6) 2016, the head and the liner were exchanged due to a pseudotumor.There is a suspicion of neck corrosion.

Manufacturer Narrative

An event regarding corrosion involving an metal head was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis was performed that concluded "debris was observed at the proximal end of the taper of the head.Eds showed the debris was consistent with biological material.No material or manufacturing defects were observed on the surfaces examined." medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the mar concluded that debris observed at the proximal end of the taper of the head was consistent with biological material.No material or manufacturing defects were observed on the surfaces examined.No further investigation for this event is possible at this time.If the additional information will be received, this investigation will be reopened and re-evaluated.

Event Description

On (b)(6) 2008, the revision from the bipolar to tha was performed.The cup and the liner are products of other companies.On (b)(6) 2016, the head and the liner were exchanged due to a pseudotumor.There is a suspicion of neck corrosion.

• Brand Name: C-TAPER COCR LFIT HEAD 28MM/+10
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5885254
• MDR Text Key: 52386471
• Report Number: 0002249697-2016-02644
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• PMA/PMN Number: K993601
• 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: 01/11/2017

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: 05/31/2011
• Device Catalogue Number: 06-2810
• Device Lot Number: JDLMHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2006
• 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
• Patient Age: 71 YR
• Patient Weight: 68