MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UHR BIPOLAR 28X49MM; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Catalog Number UH1-49-28

Device Problems Break (1069); Detachment Of Device Component (1104); Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 03/30/2016

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

Patient had bipolar component since 1996 that the inner head broke free from the outer head.

Manufacturer Narrative

An event regarding disassociation between the uhr bipolar and the femoral head involving a uhr bipolar 28x49mm 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 for evaluation.-medical records received and evaluation: the provided x-ray was reviewed by a consulting clinician who indicated a medical review could not be performed as additional records such as operative reports, and clinical information are required.-device history review: a device history review confirmed that all devices accepted into finished goods conformed to specification.-complaint history review: a complaint history review confirmed no other similar events for the reported lot.Conclusions: the event was confirmed based on the provided x-ray.However, the exact cause of the reported disassociation could not be determined because no medical records, operative reports, clinical information and devices were provided for evaluation which are needed to determine the root cause for the reported event.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopedics.If additional information and/or devices becomes available, this investigation will be reopened.

Event Description

Patient had bipolar component since 1996 that the inner head broke free from the outer head.

• Brand Name: UHR BIPOLAR 28X49MM
• 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: 5608092
• MDR Text Key: 43644178
• Report Number: 0002249697-2016-01343
• 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: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UH1-49-28
• Device Lot Number: A95T24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 49