MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 26X41MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number UH1-41-26

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

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

Event Date 12/09/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested and if received, will be provided in the supplemental report.

Event Description

Bipolar to total hip replacement revision due to dislocation.Doctor replaced bipolar head, and inner 26mm v40 head with 28mm head.He used competitor cup and dual mobility outer head.Right hip.

Manufacturer Narrative

An event regarding dislocation involving a uhr bipolar 26x41mm was reported.The event was confirmed.Method & results: -device evaluation and results: could not be performed as no items associated with the event were returned or made available for identification or evaluation.-medical records received and evaluation: the provided medical information was submitted to a consulting clinician who confirmed dislocated bipolar via the provided x-ray, but deemed the provided information insufficient for a medical review.-device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the exact cause of the event could not be determined because the product was not returned for evaluation and insufficient information was provided.Additional information, including operative reports, progress notes, 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

Bipolar to total hip replacement revision due to dislocation.Doctor replaced bipolar head, and inner 26mm v40 head with 28mm head.He used competitor cup and dual mobility outer head.Right hip.

• Brand Name: UHR BIPOLAR 26X41MM
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5316282
• MDR Text Key: 34047476
• Report Number: 0002249697-2015-04469
• Device Sequence Number: 1
• Product Code: KWL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K800207
• 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: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Catalogue Number: UH1-41-26
• Device Lot Number: MHR091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2009
• 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: 91 YR
• Patient Weight: 52