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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN CUP PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN CUP PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem No Apparent Adverse Event (3189)
Patient Problem Unspecified Infection (1930)
Event Date 12/27/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical devices: unknown stem, unknown liner, unknown head. Foreign country: (b)(6). Reported event was unable to be confirmed due to limited information received from the customer. Device history record review was unable to be performed as the lot number of the device involved in the event is unknown. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. The reported event was identified during review of a journal article. Shin, w. C. , moon, n. H. , jeon, s. B. , & suh, k. T. (2020). Comparison of surgical outcomes between standard and elevated-rim highly cross-linked polyethylene acetabular liners in primary total hip arthroplasty with minimum 15-year follow-up: single-center, retrospective cohort study. The journal of arthroplasty, 35(5), 1290-1296. Doi:10. 1016/j. Arth. 2019. 12. 026. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 ¿ 02253, 0001822565 - 2020 - 03093, 0001822565 - 2020 - 03094.
 
Event Description
It was reported in a journal article that one patient was revised due to periprosthetic joint infection. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand NameUNKNOWN CUP
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10465231
MDR Text Key204873611
Report Number0001822565-2020-03095
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 08/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/28/2020 Patient Sequence Number: 1
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