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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FEM HD 32/0MM T1; BIOLOX DELTA CERAMIC FEM HEAD
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BIOMET UK LTD. DELTA CER FEM HD 32/0MM T1; BIOLOX DELTA CERAMIC FEM HEAD Back to Search Results
Model Number N/A
Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Patient Problem Pain (1994)
Event Date 08/21/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Initial report.Report source, foreign: event occurred in (b)(6).Customer has indicated that the products will not be returned to zimmer biomet for investigation, as they remain implanted.Concomitant medical products: medical product: biolox delta cer lnr 32mm g, catalog #: 110003629, lot #: 3409704.Medical product: g7 pps ltd acet shell 58g, catalog #: 010000666, lot #: 3409704.Medical product: echo por fmrl lat nc 14x150mm, catalog #: 192114, lot #: 133930.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00035.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the initial right tha was performed on (b)(6) 2018.At the one-year visit, (b)(6) 2019, the patient experienced occasional noise.At the two-year visit, (b)(6) 2020, the patient is experiencing an increase in pain with movement and frequent noise.It was also stated by the patient that the noise was getting worse.Subsequently, the patient was prescribed with physical therapy.
 
Event Description
It was reported that the initial right tha was performed on (b)(6) 2018.At the one-year visit, (b)(6) 2019, the patient experienced occasional noise.At the two-year visit, (b)(6) 2020, the patient is experiencing an increase in pain with movement and frequent noise.It was also stated by the patient that the noise was getting worse.Subsequently, the patient was prescribed with physical therapy.
 
Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00035-1.Additional information received: medical record received (under review).Patient age: 58 years old.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the initial right tha was performed on (b)(6) 2018.At the one-year visit, on (b)(6) 2019, the patient experienced occasional noise.At the two-year visit, on (b)(6) 2020, the patient is experiencing an increase in pain with movement and frequent noise.It was also stated by the patient that the noise was getting worse.Subsequently, the patient was prescribed with physical therapy.
 
Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00035-2.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported.A review of the complaint database over the last 3 years has found no similar complaints reported with the items: 650-1162 and 110003629.Risk assessment: the root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.For item: 650-1162, lot: 2016120241: risk management report documents the estimated residual risk associated with the reported event.The reported event states increase pain with movement.In the risk file, pain is considered harm with a severity level of 3 for multiple hazards defined as moderate, which is described in the severity table as: 3: moderate prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.For item: 110003626, lot: 3409704: risk management report documents the estimated residual risk associated with the reported event.The reported event states increase pain with movement.In the risk file, pain is considered harm with a severity level of 3 for multiple hazards defined as moderate, which is described in the severity table as: 3: moderate prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.The reported event states physical therapy was prescribed (medical intervention), therefore the outcome of this complaint is considered to be within the severity of the rmf.In order to calculate the occurrence rate, sales and complaint data have been obtained, and are for a period of the last 3 years prior to the notification date, being january 2021.For item: 650-1162, lot: 2018080547: sales (january 2018 to january 2021): (b)(4) units.Complaints search was conducted for events occurring between january 2018 to january 2021 for item: 650-1162.No further complaints were identified for this item number other than (b)(4).(b)(4).For item: 110003626, lot: 3745537: sales (february 2018 to february 2021): (b)(4) units.Complaints search was conducted for events occurring between january 2018 to january 2021 for item: 110003629.No further complaints were identified for this item number other than (b)(4).(b)(4).The failure mode will be monitored through zimmer biomet internal complaint and post market surveillance activities with further review of risk conducted through these processes.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
 
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Brand Name
DELTA CER FEM HD 32/0MM T1
Type of Device
BIOLOX DELTA CERAMIC FEM HEAD
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key11284509
MDR Text Key230455224
Report Number3002806535-2021-00034
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
PMA/PMN Number
K131684
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number650-1162
Device Lot Number2016120241
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEEH10.
Patient Outcome(s) Other;
Patient Age58 YR
Patient Weight104
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