MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 28MM; CERAMIC FEMORAL HEAD PROSTHESIS

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem Joint Dislocation (2374)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is available to be returned to zimmer biomet for investigation.Medical product: cer option type 1 tpr sleve +3, catalog #: 650-1067, lot #: 3031111; medical product: vivacit-e dm bearing 28x46mm, catalog #: 110031013, lot #: 64689634.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product has not been returned.

Event Description

It was reported that the patient underwent an initial hip arthroplasty procedure on an unknown date and a revision on (b)(6) 2020.On (b)(6) 2020 the patient presented in the er with a dislocated hip.Subsequently, a second revision procedure was performed on (b)(6) 2020 due to dislocation and disassociation.During the procedure, the head, liner, bearing and sleeve were removed and replaced.This complaint reports the revision performed on (b)(6) 2020 due to dislocation and disassociation.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.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 item and lot combination.A review of the complaint database over the last 3 years has found 6 similar complaints reported with the item 650-1055.Trend identified as 2 complaints were reported from same hospital.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: risk management report documents the estimated residual risk associated with the reported event.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.The reported event states revision due to dislocation and disassociation.In the risk file, dislocation is considered harm with a severity level of 3 for a number of hazards defined as moderate, which is described in the severity table as: s-3 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 outcome of the reported event (surgical intervention) is considered to be within the severity of the rmf.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.

Event Description

On aug 4, 2020 the patient presented in the er with a dislocated hip.Subsequently, a second revision procedure was performed on (b)(6) 2020 due to dislocation and disassociation.During the procedure, the head, liner, bearing and sleeve were removed and replaced.This complaint reports the revision performed on (b)(6) 2020 due to dislocation and disassociation.

• Brand Name: CER BIOLOXD OPTION HD 28MM
• Type of Device: CERAMIC FEMORAL HEAD PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10475560
• MDR Text Key: 205277328
• Report Number: 3002806535-2020-00385
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K192683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/26/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1055
• Device Lot Number: 2964312
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 11/26/2020
• Supplement Dates FDA Received: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention