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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SECUR-FIT STEM HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SECUR-FIT STEM HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problem Mechanical Problem
Event Date 05/28/2019
Event Type  Injury  
Manufacturer Narrative

It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

 
Event Description

It was reported that the patient's right hip was revised. Patient reported he had woken up with an unusual feeling and continued to feel uncomfortable after playing golf. The e. R. Discovered that the ceramic head disassociated from the adm insert and could not reduce the patient. Intra- operatively, impingement of the stem on the poly liner was reported. The head and adm/mdm liner construct was revised to a 36 +10 head with a 10° liner. Rep provided pre-revision x-rays, explant pictures, and the revision implant sheet and reported that no further information is available.

 
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Brand NameUNKNOWN SECUR-FIT STEM
Type of DeviceHIP IMPLANT
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
sharon rivas
325 corporate drive
mahwah , NJ 07430
2018315000
MDR Report Key8727269
Report Number0002249697-2019-02351
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,OTHER
Reporter Occupation
Type of Report Initial
Report Date 06/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_JR
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2019
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 TREATMENT DATA
Date Received: 06/24/2019 Patient Sequence Number: 1
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