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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. UNKNOWN HG1 LINER HIP PROSTHESIS

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ZIMMER, INC. UNKNOWN HG1 LINER HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problem No Information (3190)
Event Date 07/01/1994
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant product(s): item #unk, unknown head, lot #unk. Item #unk, unknown stem, lot #unk. Item #unk, unknown cup, lot #unk. Item #unk, unknown screw, lot #unk. Huk, o. L. , bansal, m. , betts, f. , rimnac, c. M. , lieberman, j. R. , huo, m. H. , & salvati, e. A. (1994). Polyethylene and metal debris generated by non-articulating surfaces of modular acetabular components. The journal of bone and joint surgery, 76 b(4), 568-574. Retrieved from http://bjj. Boneandjoint. Org. Uk/content/jbjsbr/76-b/4/568. Full. Pdf. Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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
It was reported in a journal article, the back surfaces of the pe liners showed surface deformation damage causing permanent deformity on their back surfaces. Deformation had been caused by the edges of the screw holes in the metal backings and by the heads of the screws themselves. Such deformation was visible in the superior quadrant only. No further information available.
 
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Brand NameUNKNOWN HG1 LINER
Type of DeviceHIP PROSTHESIS
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6729085
MDR Text Key80575941
Report Number0001822565-2017-05007
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 company representative,litera
Reporter Occupation
Type of Report Initial
Report Date 07/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
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 Received02/04/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 07/20/2017 Patient Sequence Number: 1
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