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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RINGLOC+ REPLACEMENT RING SZ22 HIP PROSTHESIS

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ZIMMER BIOMET, INC. RINGLOC+ REPLACEMENT RING SZ22 HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problems Difficult to Insert; Difficult To Position
Event Date 05/01/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device has been discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical products: item # 16-104146, cup, lot # 640690. Item # ep-108222, liner, lot # 274340. Item # xl-108222, liner, lot # 696150. Item # 103531, bone screw, lot # 063030. Item # 103533, bone screw, lot # 064250. Item # 163667, femoral head, lot # 824420. Item # 51-108080, femoral stem, lot # 3275307. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-03932, 0001825034-2018-03933, 0001825034-2018-03934.

 
Event Description

It was reported that during an initial hip procedure, a cup was implanted. The surgeon was unable to get multiple liners to seat in the implanted cup. An attempt was made using an alternate locking ring, which was also unsuccessful. All acetabular components were removed and replaced with competitor product. The device malfunction caused a surgical delay of one hour. Attempts have been made, and no further information has been provided.

 
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Brand NameRINGLOC+ REPLACEMENT RING SZ22
Type of DeviceHIP PROSTHESIS
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 Key7592789
Report Number0001825034-2018-03935
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number106022
Device LOT Number666530
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 Received08/01/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/12/2010
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: 06/12/2018 Patient Sequence Number: 1
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