MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6021-0230

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Headache (1880); Unspecified Infection (1930); Rash (2033); Tissue Damage (2104); Injury (2348); Reaction (2414)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Catalog numbers and lot codes of other devices listed in this report: cat # mac-9988-5460, lot # unknown, description: std mitch trh cp sz 54/60, manufacturer: (b)(4); cat # mmh-9988-1454, lot # unknown, description: mitch trh md hd sz 54+4, manufacturer: (b)(4).It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.A supplemental report will be submitted upon completion of the investigation.

Event Description

The stryker product manager reported that a female patient was implanted with accolade( 60210230) and mitch (mac99885460, mmh99881454) and that a revision was undertaken due severe metal reactions.

Manufacturer Narrative

Additional information for the previously reported mitch product: cat # mmh-9988-1454, lot # unknown, description: mitch trh md hd sz 54+4, manufacturer: depuy lot# is fm073665.An event regarding altr and a accolade stem was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the reported device was not returned for evaluation.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-device history review: review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including, detailed operative reports, patient history, progress notes, pathology reports, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

The stryker product manager reported that a female patient was implanted with accolade(60210230) and mitch (mac99885460, mmh99881454) and that a revision was undertaken due severe metal reactions.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #2
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: 5754007
• MDR Text Key: 48290521
• Report Number: 0002249697-2016-02069
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2017

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: 11/30/2013
• Device Catalogue Number: 6021-0230
• Device Lot Number: 28263801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/31/2016
• Initial Date FDA Received: 06/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2008
• 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