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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 32/+3MM T1; HIP PROSTHESIS

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BIOMET UK LTD. DELTA CER FEM HD 32/+3MM T1; HIP PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Joint Dislocation (2374)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Report source: (b)(6).The investigation is in process.Once the investigation is complete, a follow-up mdr will be submitted.
 
Event Description
It was reported by the hospital that a patient underwent initial tha.Subsequently, an x-ray identified a dislocation of the head.Revision surgery was conducted to replace the liner and head.
 
Event Description
It was reported by the hospital that a patient underwent initial tha.Subsequently, an x-ray identified a dislocation of the head.Revision surgery was conducted to replace the liner and head.
 
Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.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.
 
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Brand Name
DELTA CER FEM HD 32/+3MM T1
Type of Device
HIP PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key8905256
MDR Text Key154705129
Report Number3002806535-2019-00688
Device Sequence Number1
Product Code LZO
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 09/16/2019
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 Health Professional
Device Model NumberN/A
Device Catalogue Number650-1161
Device Lot Number2018081128
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/22/2019
Initial Date FDA Received08/19/2019
Supplement Dates Manufacturer Received09/16/2019
Supplement Dates FDA Received09/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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