MAUDE Adverse Event Report: BIOMET UK LTD. RINGLOC-X E1 10DEG 52/32MM; NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER

Model Number N/A

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 11/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The product has been returned to zimmer biomet for investigation.Medical product: cocr hd lng nk 32 +4mm 12/14, catalog #: p0206l32, lot #: j3729833; medical product: exc abt rnglc-x shell pc 052mm, catalog #: 131352, lot #: 3972375; medical product: unknown screw, catalog #: unknown screw, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00178.Occupation: patient.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 a total hip arthroplasty at the (b)(6) hospital, (b)(6).Subsequently, the patient has reported that a dislocation took place on (b)(6) 2018 where he was treated at the same hospital.A further dislocation took place and the patient was revised on (b)(6) 2018, again at the same hospital.No further information has been provided.This complaint reports the revision surgery performed on (b)(6) 2018.

Event Description

It was reported that the patient underwent a total hip arthroplasty at the private (b)(6) turkey.Subsequently, the patient has reported that a dislocation took place on (b)(6) 2018 where he was treated at the same hospital.A further dislocation took place and the patient was revised on (b)(6) 2018, again at the same hospital.No further information has been provided.This complaint reports the revision surgery performed on (b)(6) 2018.

Manufacturer Narrative

(b)(4).This final / follow-up report is being submitted to relay additional information.G3: report source, foreign: event occurred in turkey.Correction: upon reassessment of the complaint, it was identified that incorrect sales data have been reported.New sales report and risk assessment: the event reports revision due to dislocation.Failure analysis report concludes: a ringloc-x e1 acetabular liner, exceed abt ringloc-x acetabular shell, ø32mm cocr femoral head and unknown screw were returned to the research department for evaluation, after they were revised after two months of service due to repeated dislocation.Damage to the plastic was reported by the patient.Damage was observed to the rim of the ringloc-x e1 acetabular liner, which may have been caused during the revision procedure, by impingement against the femoral stem during dislocation or during the reduction procedure on (b)(6) 2018.The extent of each possible contributing factor to the observed damage cannot be determined with the available information.Additional information such as patient details (age, height, weight, activity level, pre-existing conditions), radiographs and surgical notes for the primary and revision surgery are required to determine the root cause of the repeated dislocations in this instance.This information has been requested but has not been received at the time of writing this report.Risk management file documents the estimated residual risk associated with the reported event.This hazard (dislocation / subluxation) has a severity of 4 which is described in the severity table as: s-4 results in permanent impairment of body function or permanent damage to a body structure / necessitates surgical intervention.The outcome of the reported event (surgical intervention) is considered to be within the severity of the rmr.In order to calculate the occurrence rate, sales and complaint data for this item number have been obtained, and are attached for a period of the last 3 years prior to notification date, being feb 2020.Sales (feb 2017 to feb 2020): (b)(4) units.Complaints search was conducted for events occurring between feb 2017 to feb 2020 for item: ep-063252.(b)(4).Since the occurrence calculation is based on only 1 complaint, the current occurrence ratings in the risk management file are still relevant and have not been exceeded; as it is not possible to make a calculation based on one instance of a complaint.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.Multiple failure causes result in a harm of dislocation / subluxation.The root cause of the reported event has not been determined, therefore a specific failure cause cannot be selected.As a failure cause cannot be selected, the occurrence score for one hazard cannot be attributed to all events, and therefore cannot be used for comparison.If further information regarding the root cause of the reported event is provided, risk should be re-assessed.

Event Description

It was reported that the patient underwent a total hip arthroplasty at the private (b)(6) hospital, turkey.Subsequently, the patient has reported that a dislocation took place on (b)(6) 2018 where he was treated at the same hospital.A further dislocation took place and the patient was revised on (b)(6) 2018, again at the same hospital.No further information has been provided.This complaint reports the revision surgery performed on (b)(6) 2018.

Manufacturer Narrative

Cmp-(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in turkey.Summary: product has been returned to biomet uk ltd for evaluation and forwarded to a research engineer for investigation.A ringloc-x e1 acetabular liner, exceed abt ringloc-x acetabular shell, ø32 mm cocr femoral head and unknown screw were returned to the research department for evaluation, after they were revised after two months of service due to repeated dislocation.Damage to the plastic was reported by the patient.The available relevant manufacturing history records indicate that the item was manufactured and sterilised in accordance with the applicable specifications.A review of the complaint database over the last 3 years has found no similar complaints for the item ep-063252-00.Damage was observed to the rim of the ringloc-x e1 acetabular liner, which may have been caused during the revision procedure, by impingement against the femoral stem during dislocation or during the reduction procedure on (b)(6) 2018.The extent of each possible contributing factor to the observed damage cannot be determined with the available information.Additional information such as patient details (age, height, weight, activity level, pre-existing conditions), radiographs and surgical notes for the primary and revision surgery are required to determine the root cause of the repeated dislocations in this instance.This information has been requested but has not been received at the time of writing this report.The available mhr reviews indicates that the product was most likely conforming to design specification when it left zimmer biomet control, however it is not possible to confirm the root cause of the revision with the information available.Summary of medical records and/or x-ray records review: radiographs have been requested, but have not been received at the time of writing this report, therefore an assessment of the initial components sizing, positioning and alignment could not be made.Ifu and/or surgical procedure reference: the instructions for use provided with the ringloc-x e1 acetabular liner provides the following guidance: warnings and precautions: -improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.-misalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure.-do not modify implants unless specified in the operative technique.-do not use any component that is nicked, scratched, chipped or otherwise altered.Possible adverse effects: dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.Risk assessment: the event reports revision due to dislocation.Failure analysis report concludes: a ringloc-x e1 acetabular liner, exceed abt ringloc-x acetabular shell, ø32mm cocr femoral head and unknown screw were returned to the research department for evaluation, after they were revised after two months of service due to repeated dislocation.Damage to the plastic was reported by the patient.Damage was observed to the rim of the ringloc-x e1 acetabular liner, which may have been caused during the revision procedure, by impingement against the femoral stem during dislocation or during the reduction procedure on (b)(6) 2018.The extent of each possible contributing factor to the observed damage cannot be determined with the available information.Additional information such as patient details (age, height, weight, activity level, pre-existing conditions), radiographs and surgical notes for the primary and revision surgery are required to determine the root cause of the repeated dislocations in this instance.This information has been requested but has not been received at the time of writing this report.Risk management file documents the estimated residual risk associated with the reported event.This hazard (dislocation/subluxation) has a severity of 4 which is described in the severity table as: s-4 results in permanent impairment of body function or permanent damage to a body structure / necessitates surgical intervention.The outcome of the reported event (surgical intervention) is considered to be within the severity of the rmr.In order to calculate the occurrence rate, sales and complaint data for this item number have been obtained, and are attached for a period of the last 3 years prior to notification date, being feb 2020.- sales (feb 2017 to feb 2020) = (b)(4) units.- complaints search was conducted for events occurring between (b)(6).2017 to (b)(6).2020 for item (b)(4).- no other complaints were identified for this item number other than cmp-(b)(4).- therefore, the calculated occurrence rate is 1 in (b)(4).- since the occurrence calculation is based on only 1 complaint, the current occurrence ratings in the risk management file are still relevant and have not been exceeded; as it is not possible to make a calculation based on one instance of a complaint.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.- multiple failure causes result in a harm of dislocation/subluxation.The root cause of the reported event has not been determined, therefore a specific failure cause cannot be selected.As a failure cause cannot be selected, the occurrence score for one hazard cannot be attributed to all events, and therefore cannot be used for comparison.If further information regarding the root cause of the reported event is provided, risk should be re-assessed.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.

• Brand Name: RINGLOC-X E1 10DEG 52/32MM
• Type of Device: NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9863709
• MDR Text Key: 190136106
• Report Number: 3002806535-2020-00177
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2020

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: EP-063252
• Device Lot Number: 6002209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/22/2020
• Supplement Dates Manufacturer Received: 08/14/2020; 08/26/2020
• Supplement Dates FDA Received: 08/26/2020; 08/28/2020
• 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