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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN HEAD PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN HEAD PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Corroded (1131)
Patient Problems Loss of Range of Motion (2032); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Journal article: waterson, h. B. , whitehouse, m. R. , greidanus, n. V. , garbuz, d. S. , masri, b. Z. , duncan, c. P. (2018). Revision for adverse local tissue reaction following metal-on-polyethylene total hip arthroplasty is associated with a high risk of early major complications, the british editorial society of bone & joint surgery. 100-b:720¿4. Https://doi. Org/10. 1302/0301-620x. 100b6. Bjj-2017-1466. R1. Concomitant medical products: item# unknown unknown stem lot# unknown. Item# unknown unknown liner lot# unknown. Item# unknown unknown cup lot# unknown. Foreign source - (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported in journal article that patient underwent total hip arthroplasty on an unknown date. Patient underwent revision due to difficulty with flexion in vivo implant corrosion, and altr. Attempts were made to obtain additional information; however, none was available.
 
Manufacturer Narrative
(b)(4). This report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information provided. Device history record (dhr) review was unable to be performed as the lot number was not provided. Root cause could not be determined with the information provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
No further event information available at the time of this report.
 
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Brand NameUNKNOWN HEAD
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7903270
MDR Text Key121511470
Report Number0001822565-2018-05158
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
PNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/12/2018
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
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 09/24/2018 Patient Sequence Number: 1
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