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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 14X150MM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ECHO POR FMRL LAT NC 14X150MM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems Muscle Spasm(s) (1966); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544)
Event Date 01/12/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4) multiple mdr's were reported for this event. Please also see associated events: 0001825034-2018-01605. Concomitant medical products: 010000667 g7 pps ltd acet shell 60, lot 3575465. The 650-1160 delta cer fem hd 32/+6 mm t1 lot 2015110412. The 110003629 biolox delta cer lnr 32 mm g lot 3409704/ (b)(6). Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no furth er action is required as no were trends identified. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. 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. Device remains implanted.
 
Event Description
It was reported that three months after a total hip arthroplasty procedure was performed on the right hip the patient reported pain, discomfort, difficulty walking, and difficulty performing usual activities at the 3 month follow up. It was also reported that the patient found it difficult to do shopping and that the pain interfered with usual work at the 3 month follow-up. The patient reported at the 1 year follow up that there were no problems performing usual activities; however, severe pain - 'shooting', 'stabbing', or 'spasms' was reported for one or two days within the past four weeks. The satisfaction score at the 1-year followup visit was 9. Attempts have been made and additional information on the reported event is unavailable.
 
Manufacturer Narrative
Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event. The initial report was submitted in error and should be voided.
 
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Brand NameECHO POR FMRL LAT NC 14X150MM
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7305852
MDR Text Key101257650
Report Number0001825034-2018-01604
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
PMA/PMN Number
PK070274
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2020
Device Model NumberN/A
Device Catalogue Number192114
Device Lot Number013570
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 03/01/2018 Patient Sequence Number: 1
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