MAUDE Adverse Event Report: BIOMET UK LTD. BI-METRIC HAP 12X140 MM; HIP PROTHESIS

Model Number N/A

Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 02/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded by the hospital.Concomitant medical products: cer bioloxd mod hd 38mm -6 nk, catalog #: 12-115130, lot #: unknown.Medical product: m2a-38 cup non flared sz 52mm, catalog #: 15-106052, lot #: 143810.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00203.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported by clinical study for eu11 ceramic-on-metal v mom using m2a-38 cup in cementless tha (339) that the patient initially underwent a right total hip arthroplasty.Subsequently, the patient was revised on due to pseudotumors and infection.The patient was then removed from the study due to revision of components.

Event Description

It has been reported by clinical study for eu11 ceramic-on-metal v mom using m2a-38 cup in cementless tha (339) that the patient initially underwent a right total hip arthroplasty.Subsequently, the patient was revised on due to pseudotumors and infection.The patient was then removed from the study due to revision of components.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in united kingdom.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with 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 (b)(4).A review of sterilization certificate confirms product received radiation within the specified standard range.An x-ray was provided and reviewed by an hcp on linked complaint ((b)(4)).The review concluded possible focal osteopenia involving the greater trochanter suggesting osteolysis and a possible fracture involving the lateral cortex of the proximal femoral diaphysis.The fit and alignment of the implants was noted as appropriate.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: this item has been rationalized, and is no longer referenced in us or uk risk files.As a risk file cannot be selected, a risk assessment cannot be conducted.This matter will be escalated at the complaints trending meeting (data trend analysis) for determination of potential further action.No corrective or preventive actions are deemed necessary a t this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

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, h10.G3: report source, foreign - event occurred in united kingdom.Correction: risk assessment has been re-assessed: (b)(4) reports infection and pseudotumors which resulted in a revision 10 years post primary.There is no information provided in the complaint to conclude the cause of the reported issues, however the applicable risk file assessment of the severity outcome of this complaint (surgical intervention) concludes that the severity assigned to the harm of infection is exceeded as it is considered severity of 3 ¿ necessitates minor medical intervention.The risk file will be updated to reflect the severity reported within this complaint.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It has been reported by clinical study for eu11 ceramic-on-metal v mom using m2a-38 cup in cementless tha (339) that the patient initially underwent a right total hip arthroplasty.Subsequently, the patient was revised on due to pseudotumors and infection.The patient was then removed from the study due to revision of components.

• Brand Name: BI-METRIC HAP 12X140 MM
• Type of Device: HIP PROTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9937889
• MDR Text Key: 196914464
• Report Number: 3002806535-2020-00231
• Device Sequence Number: 1
• Product Code: LPH
• 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: foreign,health professional,s
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2020

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 Expiration Date: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 162032
• Device Lot Number: 1772937
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 07/03/2020; 07/03/2020
• Supplement Dates FDA Received: 07/16/2020; 08/03/2020
• 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
• Patient Weight: 64