MAUDE Adverse Event Report: BIOMET UK LTD. CER OPTION TYPE 1 TPR SLEVE -6; FEMORAL HEAD/STEM PROSTHESIS ADAPTOR

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	12/07/2015
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: medical product: cer bioloxd option hd 28mm, catalog #: 650-1055, lot #: 727470.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00089.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 had an initial right hip replacement.Subsequently, the patient was revised due to complications with metal on metal implants.Patient was again revised due to leg length discrepancy.This complaint is reporting the revision due to the leg length discrepancy.Attempts were made to obtain additional information; however, none was available.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.D11: medical product: cer bioloxd option hd 28mm, catalog #: 650-1055, lot #: 727470.Medical product: m2a-magnum recap cup 58odx52id, catalog #: 157858, lot #: 043360.Medical product: act artic e1 hip brg 28x52mm, catalog #: ep-200158, lot #: 235260.Medical product: m2a-magnum 52-60mm tpr insrt-6, catalog #: 139264, lot #: 004100.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00089-1.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 these items.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: the event reports hip revision due leg length discrepancy.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 hip revision due leg length discrepancy.The severity score is 3, which is defined in the rmr as: 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.Corrective action taken: no corrective action required at this time.Preventive action taken: no preventive action required 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 had an initial right hip replacement.Subsequently, the patient was revised due to complications with metal on metal implants.Patient was again revised due to leg length discrepancy.This complaint is reporting the revision due to the leg length discrepancy.Attempts were made to obtain additional information; however, none was available.

• Brand Name: CER OPTION TYPE 1 TPR SLEVE -6
• 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: 9727198
• Report Number: 3002806535-2020-00088
• Device Sequence Number: 2500452
• Product Code: LZO
• UDI-Device Identifier: 00880304521926
• UDI-Public: 00880304521926
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K082996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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 Expiration Date: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 650-1064
• Device Lot Number: 265000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 05/15/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEEH10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention