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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZIMMER MMC, CUP, UNCEMENTED, 54 MM/46 MM, CODE L ZIMMER MMC CUP

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ZIMMER SWITZERLAND MANUFACTURING GMBH ZIMMER MMC, CUP, UNCEMENTED, 54 MM/46 MM, CODE L 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); Bone Fracture(s) (1870); Muscle Weakness (1967); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)
Event Date 04/18/2018
Event Type  Injury  
Manufacturer Narrative
This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states. Medical products: metasul ldh, head, 46, code l, taper 18/20; catalog#: 01. 00181. 460; lot#: 2431254. Metasul ldh, head adapter, m, 0, taper 12/14-18/20; catalog#: 01. 00185. 146; lot#: 2516387. Femoral stem press-fit collarless 12/14 neck taper standard body standard neck offset size 13 138mm stem length cementless; catalog#: 00-7864-013-00; lot#: 61256425. Therapy date: (b)(6) 2018. 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 was implanted on the right side and underwent a revision surgery due to alval, pelvic ring fracture, muscle weakness and muscle destruction due to alval, elevated metal ion levels, pseudocyst with fluid collection, trunnionosis with a blackened trunnion and fibrous component on the acetabular component. There was approximately 2000ml blood loss during revision surgery.
 
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Brand NameZIMMER MMC, CUP, UNCEMENTED, 54 MM/46 MM, CODE L
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 Key11855226
MDR Text Key251894965
Report Number0009613350-2021-00232
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
Report Date 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Model NumberN/A
Device Catalogue Number01.00634.054
Device Lot Number2528363
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 Received09/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/24/2009
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: 05/20/2021 Patient Sequence Number: 1
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