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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM US ACET CMPNT 54/48 N PROSTHESIS, HIP, SEMI-CONSTRAINED

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ZIMMER SWITZERLAND MANUFACTURING GMBH DUROM US ACET CMPNT 54/48 N PROSTHESIS, HIP, SEMI-CONSTRAINED Back to Search Results
Model Number N/A
Device Problems Material Erosion (1214); Patient Device Interaction Problem (4001)
Patient Problems Bone Fracture(s) (1870); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
Event Date 04/29/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: metasul ldh, head, 48, code n, taper 18/20 item#01. 00181. 480 lot#2435670. Metasul ldh, head adapter, s, -4, taper 12/14- 18/20 item#01. 00185. 145 lot#2408136. M/l taper hip prosthesis item#7711-10-40 lot#61158160. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. If multiple reports submitted for the event, use following statement: multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2022 - 00303, 0009613350 - 2022 - 00304.
 
Event Description
It was reported that the patient was implanted on left hip and underwent revision surgery approximately ten years post-implantation due to pain and metallosis. Peroprosthetic greater trochanteric fracture and osteolysis were noted during revision surgery attempts have been made and no further information has been provided.
 
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Brand NameDUROM US ACET CMPNT 54/48 N
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key14494573
MDR Text Key292571441
Report Number0009613350-2022-00301
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/15/2013
Device Model NumberN/A
Device Catalogue Number01.00214.154
Device Lot Number2435696
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2008
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: 05/25/2022 Patient Sequence Number: 1
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