MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 26X42MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number UH1-42-26

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 04/05/2014

Event Type  Injury  

Event Description

It was reported that patient dislocated unknown bipolar hip.

Event Description

It was reported that patient dislocated unknown bipolar hip.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown bipolar hip.An evaluation of the device cannot be performed as the device was sent to pathology and was not returned to the manufacturer.Additional information (including x-rays and medical records) has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Manufacturer Narrative

An event regarding dislocation involving an unknown bipolar hip was reported.The provided medical information was submitted to a consulting clinician who deemed it insufficient for a medical review.Confirmed dislocation on x-ray.A device history review could not be performed as the reported device lot code was not provided.The event was confirmed but the root cause could not be determined because the devices were not returned for evaluation and insufficient medical information was provided.

Manufacturer Narrative

An event regarding dislocation involving a uhr bipolar 26x42mm was reported.The event was confirmed.-device history review: indicated all devices accepted into final stock met specifications.-complaint history review: there have been no other events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient medical records were provided for medical review.No further investigation is required at this time.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that patient dislocated unknown bipolar hip.

• Brand Name: UHR BIPOLAR 26X42MM
• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3778550
• MDR Text Key: 4433770
• Report Number: 0002249697-2014-01551
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: UH1-42-26
• Device Lot Number: MMNR1J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2013
• 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: 82 YR
• Patient Weight: 61