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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNKNOWN CUP PROSTHESIS HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Death (1802); Unspecified Infection (1930)
Event Date 06/06/2018
Event Type  Death  
Manufacturer Narrative
(b)(4). Concomitant medical products: unknown liner; unknown head; unknown stem. (b)(6). Literature: h. B. Waterson, m. R. Whitehouse, n. V. Greidanus, d. S. Garbuz, b. A. Masri, c. P. Duncan. "revision for adverse local tissue reaction following metal-on-polyethylene total hip arthroplasty is associated with a high risk of early major complications - (b)(6) 2018. Multiple mdr reports were filed for this event; please see associated reports: 0001822565-2018-05296 and 0001822565-2018-05298. It is unknown if product will be returning to zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that one patient post revision for adverse reaction to metal debris (armd) and trunnionosis developed deep infection. It was treated with first stage prostalac antibiotic spacer. The second stage was deferred due to medical reasons. The patient died one year after the first stage spacer surgery was done. Prior to diagnosis of infection, patient presented with instability.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. 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
No additional information received.
 
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Brand NameUNKNOWN CUP
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 Key7911477
MDR Text Key121797978
Report Number0001822565-2018-05295
Device Sequence Number1
Product Code KWA
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/07/2018
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

Patient Treatment Data
Date Received: 09/26/2018 Patient Sequence Number: 1
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