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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. SHELL 44 MM O.D. PROSTHESIS, HIP

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ZIMMER MANUFACTURING B.V. SHELL 44 MM O.D. PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Unspecified Infection (1930); Patient Problem/Medical Problem (2688)
Event Date 10/15/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: zimmer liner cat#00500104428, lot#64302970. Zimmer stem cat#00771101010, lot#64172709. Zimmer head cat#00877502802, lot#2992432. Foreign report source: (b)(6). The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2020 - 00159. 0001822565 - 2020 - 00828.
 
Event Description
It was reported the patient developed fever and wound exudation approximately 1 week after initial tha and was given anti-infection treatment, wound debridement and dressing change. Approximately 3 weeks later, patient underwent debridement surgery. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
Reported event was confirmed with medical records provided. Review of the available records identified the following: after revision, the patient developed pulmonary infection and underwent a wound debriment procedure. Yellow exudate was observed. Peroxide and antibiotics were applied to the wound. No other complications / significant findings related to the reported event were noted. Review of the device history records identified no deviations or anomalies during manufacturing. A definitive root cause cannot be determined. A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device. 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 NameSHELL 44 MM O.D.
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
MDR Report Key9819551
MDR Text Key191128810
Report Number0002648920-2020-00160
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
PMA/PMN Number
K833991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number00500104400
Device Lot Number64316784
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/11/2020 Patient Sequence Number: 1
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