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

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Concomitant medical products: act artic e1 hip brg 28x46mm, catalog #: ep-200152, lot #: 831320; hip-taperloc-stems-unk, catalog #: unknown, lot #: 6545918; hip-magnum- cup-unk, catalog #: unknown, lot #: 088000.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent right total hip arthroplasty on an unknown date.Subsequently, the patient was revised due to dislocation.The active articulation bearing and ceramic head were removed and replaced.
Additional Manufacturer Narrative
(b)(4).As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.In addition, 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 650-1065.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.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.Therefore, the outcome of the reported event (surgical intervention) is in line with 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 or Problem Description
It was reported that the patient underwent right total hip arthroplasty on an unknown date.Subsequently, the patient was revised due to dislocation.The active articulation bearing and ceramic head were removed and replaced.

• Brand Name: CER BIOLOXD OPTION HD 28MM
• Common Device Name: FEMORAL HEAD/STEM PROSTHESIS ADAPTOR
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10200131
• Report Number: 3002806535-2020-00294
• Device Sequence Number: 1073483
• Product Code: LPH
• UDI-Device Identifier: 00880304521919
• UDI-Public: 00880304521919
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K082996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1065
• Device Lot Number: 2958709
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention