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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZIMMER MMC, CUP, UNCEMENTED, 52 MM/44 MM, CODE J; HIP PROSTHESIS

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ZIMMER SWITZERLAND MANUFACTURING GMBH ZIMMER MMC, CUP, UNCEMENTED, 52 MM/44 MM, CODE J; HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problem Metal Related Pathology (4530)
Event Date 10/22/2021
Event Type  Injury  
Manufacturer Narrative
The manufacturer did not receive x-rays, or other source documents for review.The lot number of the device was received.The device history records will be reviewed during investigation.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).Remains implanted.
 
Event Description
It was reported that, metallosis, pseudotumor,elevated cr and cobalt blood levels.Patient outcome- metallosis.
 
Event Description
It was reported that, metallosis, pseudotumor,elevated cr and cobalt blood levels.Patient outcome- metallosis.
 
Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of initial medwatch.New information received: implantation date patient id and age.Zimmer biomet (winterthur) will proceed with the investigation.An additional report will be submitted as soon as the investigation results are available.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2021-00589.
 
Manufacturer Narrative
Investigation results were made available.Event description: it was reported that the patient had metallosis, pseudotumor, and elevated cr and cobalt blood levels.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.Dhr review: review of the device history records identified the following deviations and/or anomalies: deviation#: 09/10064.Ncr(s): no ncr with a potential correlation to the reported event was found.Conclusion: it was reported that the patient had metallosis, pseudotumor, and elevated cr and cobalt blood levels.Based on the investigation the reported event cannot be confirmed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
 
Event Description
Investigation has been completed.
 
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Brand Name
ZIMMER MMC, CUP, UNCEMENTED, 52 MM/44 MM, CODE J
Type of Device
HIP PROSTHESIS
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 Key12842648
MDR Text Key280998732
Report Number0009613350-2021-00589
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K091003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date05/31/2020
Device Model NumberN/A
Device Catalogue Number01.00634.052
Device Lot Number2554911
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/22/2021
Initial Date FDA Received11/19/2021
Supplement Dates Manufacturer Received12/10/2021
01/17/2022
Supplement Dates FDA Received01/03/2022
01/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2010
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 Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age81 YR
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