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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. RLOC-X E1 H/W +3MM 50/36MM 23; NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER
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BIOMET UK LTD. RLOC-X E1 H/W +3MM 50/36MM 23; NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER Back to Search Results
Model Number N/A
Device Problems Break (1069); Fracture (1260); Patient Device Interaction Problem (4001)
Patient Problems Bone Fracture(s) (1870); Swelling (2091); Joint Dislocation (2374); Fluid Discharge (2686); No Code Available (3191); Metal Related Pathology (4530)
Event Date 08/06/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.Medical product: delta cer fm hd 036/0mm 12/14, catalog #: 650-0837, lot #: 2016041693; medical product: regen/rnglc+ ltd 52mm sz 23, catalog #: pt-116052 lot #: 716290; medical product: taperloc bmpc 11.0x142mm 12/14, catalog #: 650-0554bm, lot #: 3916225.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00181.Due to the fact that this is a legal claim, our legal department has been provided with the relevant facts from the customer.Zimmer gmbh (b)(6) legal department is well trained and passes all the information concerning the case to our complaint handling department.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
On (b)(6) 2017, the patient underwent a right hip replacement surgery at hospital (b)(6).Subsequently, on (b)(6) 2018, the patient underwent a first revision surgery at hospital (b)(6).The description of the first revision surgery of (b)(6) 2018 reads as follows: "it is found at the supra-fascial level, as reported on the mri, swelling and dark-black content with dark serous fluid as well as signs of tissue metallosis.The hip is dislocated and the head is found in contact with the cup due to the fracture of the polyethylene component which is removed in pieces; it is removed the cup, which appears worn inside with the retentive ring fractured; removal of all tissue presenting signs of metallosis".This report is based on allegations set forth in patients notice and the allegations there in are unverified.
 
Event Description
On (b)(6) 2017, the patient underwent a right hip replacement surgery at hospital (b)(6)(performed by dr.(b)(6).Subsequently, on (b)(6) 2018, the patient underwent a first revision surgery at hospital (b)(6) (performed by dr.(b)(6).The description of the first revision surgery on (b)(6) 2018 reads as follows: " it is found at the supra-fascial level, as reported on the mri, swelling and dark-black content with dark serous fluid as well as signs of tissue metallosis.The hip is dislocated and the head is found in contact with the cup due to the fracture of the polyethylene component which is removed in pieces; it is removed the cup, which appears worn inside with the retentive ring fractured; removal of all tissue presenting signs of metallosis"; this report is based on allegations set forth in patients notice and the allegations there in are unverified.
 
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: 3002806535-2020-00181-1.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 1 similar complaints reported with these items ep-083650 and 650-0837.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly h3 other text : product not returned.
 
Event Description
It was reported that the patient underwent a right hip replacement surgery at (b)(6).Subsequently, a revision surgery was performed due to fracture of the polyethylene component.The cup was removed.It appears worn inside with the retentive ring fractured.This report is based on allegations set forth in patients notice and the allegations there in are unverified.
 
Manufacturer Narrative
(b)(4).This final / follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h6, h10.G3: report source, foreign - event occurred in italy.Multiple mdr reports were filed for this event.Additional information: radiographs received: post primary surgery and post revision surgery.As the product has not been received, the investigation was limited to the information provided; a review of radiographs, device history records and complaint history.The event reports revision due to fracture of polyethylene component.Radiographs: two radiographs taken post primary surgery and post revision surgery were reviewed by the scientific marketing associate director.The post primary radiograph shows that the positioning of the ringloc shell has high inclination and too high anteversion.When this malpostion is combined with hi-wall +3mm liner, an edge-loading situation was unavoidable.This edge-loading situation is responsible for the high amount of wear and for the fracture of the polyethylene liner.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 2 similar complaints reported with these items ep-083650 and 650-0837.The reported event and subsequent review of x-rays suggests that the root cause of the implant fracture is improper positioning.New risk assessment: the reported event and subsequent review of x-rays suggests that the root cause of the implant fracture is improper positioning.This hazard is assessed in line 16 within the rmf and anticipates the effect to be patient suffers pain and / or poor (or loss of) hip function.This is considered a severity score of 4 which is defined as results in permanent impairment of body function or permanent damage to a body structure / necessitates surgical intervention, which is in line with the reported outcome of the event.No corrective or preventative action required at this time.Due to fact that this is a legal claim, our legal department has been provided with the relevant facts from the customer.Further information concerning the case will be provided by the legal department to our complaint handling department as and when it becomes available.
 
Manufacturer Narrative
Upon further review, it was determined that this complaint is a duplicate.Therefore, this medwatch report should not have been filed as it is also a duplicate report given this information, this medwatch will be voided.The reporting of this incident has already been initiated and will continue in mdr report numbers: 3002806535-2018-01061; 3002806535-2018-01063.
 
Event Description
Upon further review, it was determined that this complaint is a duplicate.Therefore, this medwatch report should not have been filed as it is also a duplicate report given this information, this medwatch will be voided.The reporting of this incident has already been initiated and will continue in mdr report numbers: 3002806535-2018-01061 & 3002806535-2018-01063.
 
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Brand Name
RLOC-X E1 H/W +3MM 50/36MM 23
Type of Device
NON-CONSTRAINED POLYETHYLENE ACETABULAR LINER
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK   CF31 3XA
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key9864350
MDR Text Key190136636
Report Number3002806535-2020-00180
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 12/15/2023
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/28/2021
Device Model NumberN/A
Device Catalogue NumberEP-083650
Device Lot Number3911568
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
SEEH10
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexFemale
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