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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. M2A 38MMX52MM CUP PROSTHESIS, HIP

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ZIMMER BIOMET, INC. M2A 38MMX52MM CUP PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930); Pain (1994); Local Reaction (2035); Impaired Healing (2378)
Event Date 10/14/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 04995, 0001825034 - 2019 - 05016.
 
Event Description
It was reported that following a revision procedure, patient experienced dehiscence with persistent drainage from the surgical site; therefore, superficial incision and drainage of the site was performed. The patient again continued to experience persistent wound complications and underwent a second revision approximately 4 months later. During the revision, the patient was noted to have unresolved adverse reaction to metal debris, trunnion corrosion, and metallosis. The stem was left in place, and all other components were revised without complication. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameM2A 38MMX52MM 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 Key9295058
MDR Text Key165560314
Report Number0001825034-2019-04989
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 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2013
Device Model NumberN/A
Device Catalogue NumberRD118852
Device Lot Number394060
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 Received03/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/27/2003
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/08/2019 Patient Sequence Number: 1
Treatment
ACT ARTIC E1 HIP BRG CAT# EP-200144 LOT# 783940; BIOLOXD OPTION HD 28MM CAT# 650-1055 LOT# 2898737; MLRY-HD LAT POR FMRL CAT#11-104210 LOT#174310; OPTION TYPE 1 SLEVE 6 CAT#650-1068 LOT#2904643
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