MAUDE Adverse Event Report: BIOMET UK LTD. CER OPTION TYPE 1 TPR SLEVE -3; FEMORAL HEAD/STEM PROSTHESIS ADAPTOR

Model Number N/A

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

Patient Problems Loss of Range of Motion (2032); Discomfort (2330)

Event Date 06/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial mdr report.Customer has indicated that the product is available to be returned to zimmer biomet for investigation.Concomitant medical products: medical product: cer bioloxd option hd 40mm, catalog #: (b)(4), lot #: 2957976.Medical product: g7 hi-wall e1 liner 40mm f, catalog #: (b)(4), lot #: 6592120.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00336.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 patient underwent an initial hip arthroplasty.Subsequently, the patient was revised due to poly liner detachment from cup.During the procedure, the head was noted to have articulated on the metal cup, so both the head and liner components were removed and replaced.Patient experienced discomfort and restricted daily activities.Attempts have been made and additional information on the reported event is unavailable at this time.

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: 3002806535-2020-00336-1.Product has been returned to biomet uk ltd for evaluation and forwarded to a research engineer for investigation.A biolox delta option femoral head and a g7 hi-wall e1 liner were revised after the liner disassociated from the acetabular shell after approximately 3 months and a half in use.The available relevant manufacturing history record indicate that the items were manufactured in accordance with the applicable specifications.Visual inspection of the ceramic head showed a large metal transfer patch on its bearing surface, consistent with the reported liner disassociation and metallosis described in the provided surgical notes.Visual inspection of the g7 hi-wall e1 liner showed extensive damage, as well as some scratches to the bearing surface, around the region of the high wall, also consistent with the reported disassembly of the component form the acetabular shell.The provided surgical notes state that the acetabular polyethylene liner exhibited wear pattern associated with malposition and inappropriate weight distribution.Other factors that may have contributed to the early failure of the implant cannot be discussed without provision of the requested radiographs.The available mhr reviews indicate that the products were most likely conforming to design specification when they left zimmer biomet control.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.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 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.

Event Description

It was reported that the patient underwent an initial hip arthroplasty.Subsequently, the patient was revised due to poly liner detachment from cup.During the procedure, the head was noted to have articulated on the metal cup, so both the head and liner components were removed and replaced.Patient experienced discomfort and restricted daily activities.

• Brand Name: CER OPTION TYPE 1 TPR SLEVE -3
• Type of Device: FEMORAL HEAD/STEM PROSTHESIS ADAPTOR
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10332401
• MDR Text Key: 201388076
• Report Number: 3002806535-2020-00337
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K082996
• 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: 12/17/2020

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: 650-1065
• Device Lot Number: 2936757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 12/17/2020
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SRRH10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR