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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MM MOD HD +3MM NK PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A 38MM MOD HD +3MM NK PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Noise, Audible (3273)
Patient Problems Host-Tissue Reaction (1297); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 11-103203 taperloc por lat fmrl 9x137 667660. Rd118854 m2a 38mmx54mm cup 283081. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The product location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 05773 taper. 0001825034 - 2019 - 05774 cup.
 
Event Description
It was reported by 411 group that patient underwent left total hip arthroplasty sixteen years prior. Subsequently, patient may undergo a revision on an unknown date due to squeaking, discomfort and cysts in pelvis. Sales rep was inquiring about implant records. Attempts were made to obtain additional information; however, none was available.
 
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Brand NameM2A 38MM MOD HD +3MM NK
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 Key9524222
MDR Text Key188994559
Report Number0001825034-2019-05775
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2013
Device Model NumberN/A
Device Catalogue Number11-173663
Device Lot Number421620
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 Received04/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2003
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: 12/27/2019 Patient Sequence Number: 1
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