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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZIMMER MMC, CUP, UNCEMENTED, 56 MM/48 MM, CODE N ZIMMER MMC CUP

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ZIMMER SWITZERLAND MANUFACTURING GMBH ZIMMER MMC, CUP, UNCEMENTED, 56 MM/48 MM, CODE N ZIMMER MMC CUP Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
Patient Problems Cyst(s) (1800); Failure of Implant (1924); Pain (1994); Depression (2361); Osteolysis (2377); Metal Related Pathology (4530); Swelling/ Edema (4577)
Event Date 10/14/2020
Event Type  Injury  
Manufacturer Narrative
This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states. Medical products: metasul ldh, head adapter, s, -4, taper 12/14-18/20; catalog#: 01. 00185. 145; lot#: 2565568. Metasul ldh, head, 48, code n, taper 18/20; catalog#: 01. 00181. 480; lot#: 2551767. Femoral stem beaded fullcoat 12/14 neck taper std. Body std. Offset size 11 11 mm distal dia. 160 mm length; catalog #: 00-7843-011-06; lot#: 61710257. Therapy date: (b)(6) 2020. The manufacturer received other source documents for review. The manufacturer did not receive the device for investigation. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. Zimmer biomet¿s reference number of this file is (b)(4).
 
Event Description
Patient underwent an initial right hip resurfacing which was converted into a right tha due to femoral neck fracture. The patient showed no symptoms after this until he presented with pain, swelling, elevated metal ion levels and osteolysis and hence underwent a second revision surgery. During the second revision surgery a large metallosis fluid collection in the deep subcutaneous tissue, pseudotumor, moderate trunionosis around the base of the trunnion and significant metallosis within the acetabulum and cavitary osteolytic defects were reported.
 
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Brand NameZIMMER MMC, CUP, UNCEMENTED, 56 MM/48 MM, CODE N
Type of DeviceZIMMER MMC CUP
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 Key11957648
MDR Text Key255054907
Report Number0009613350-2021-00267
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 05/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Model NumberN/A
Device Catalogue Number01.00634.056
Device Lot Number2564524
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2010
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: 06/08/2021 Patient Sequence Number: 1
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