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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. STAGE ONE SELECT HIP SPACER HIP NECK LENGTH ADAPTER PROSTHESIS, HIP

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ZIMMER, INC. STAGE ONE SELECT HIP SPACER HIP NECK LENGTH ADAPTER PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Congestive Heart Failure (1783); Death (1802); Dyspnea (1816); Hypoxia (1918); Unspecified Infection (1930); Pneumonia (2011); Urinary Tract Infection (2120); Ulcer (2274)
Event Date 04/22/2015
Event Type  Death  
Manufacturer Narrative
This follow-up report is being submitted to relay additional/updated 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.
 
Manufacturer Narrative
(b)(4). This follow-up report is being submitted to relay additional information.
 
Event Description
It was reported patient presented with several pressure ulcers at the right/left heels and coccyx sacral areas after admission to extended convalescent facility. Patient developed uti, respiratory pneumonia over 2 days evidenced by dyspnea and hypoxia with a worsening cardiac status showing congestive heart failure while residing in extended convalescent facility. Patient was subsequently readmitted to the hospital with sirs (systemic inflammatory response syndrome) secondary to pji complicated by chf, worsening respiratory and skin infections. One week after hospital admission, patient expired due to right hip infection leading to sepsis.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies relevant to the reported event were found. 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.
 
Manufacturer Narrative
(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. Concomitant medical products: unk, unknown versys stem, unk; unk, unknown head, unk; unk, unknown shell, unk. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 05839; 0001822565 - 2017 - 05841; 0001822565 - 2017 - 05842.
 
Event Description
It was reported by patients legal counsel that the patient expired approximately two months post-implantation due to systemic septic infection, ulcers, uti, respiratory pneumonia, dyspnea, hypoxia and congested heart failure. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameSTAGE ONE SELECT HIP SPACER HIP NECK LENGTH ADAPTER
Type of DevicePROSTHESIS, HIP
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 Key6802276
MDR Text Key101506968
Report Number0001822565-2017-05840
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK080979
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,health p
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number431187
Device Lot Number109860
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 Received09/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2014
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: 08/17/2017 Patient Sequence Number: 1
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