MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI TWIN-PEG FEMORAL MD; OXFORD PKS HIGH FLEX TWIN PEG CEMENTED FEMUR - MEDIUM

Model Number N/A

Device Problems Problem with Sterilization (1596); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Occupation: surgery lead.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during surgery, when the foam lying on the oxford implant was removed, the implant stuck to the foam and fell to the floor.The surgery was completed by using the same item having another lot number.5 minutes delay.No harm reported.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in (b)(6).Products have been returned to biomet uk ltd for evaluation and forwarded to the complaints product evaluation engineer for investigation.The event reports that it was identified that the top foam was adhered to the tyvek lid, which resulted in the implant being projected into the floor.This event occurred during surgery.A non-clinically significant (5mins) delay to surgery was reported.The surgery was completed with an alternative implant with the same item number.The complaint has been confirmed following review of the returned packaging, which has evidence to suggest that the top foam was adhered to the tyvek lid (transfer of material between the top foam and the tyvek lid).A review of the device history records did not identify any discrepancies that would have contributed to the reported event.56 complaints were identified for this item number including (b)(4).A complaint history review identified no similar complaints for the same lot number.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.The ifu provided with the device states to check the packaging for damage before use.The likely condition of the device when it left zimmer biomet is non-conforming to specification.The correct packaging materials and sealing methods have been used.The likely cause of the reported event is not enough clearance between the top foam and the tyvek lid during the heat sealing process.This causes unintended heat transfers between the top foam and the tyvek lid, resulting in adhesion.The indent in the top foam (which have been caused by compression from the device) further indicate that the space within the blister would have been limited.Severity assessment: the event reports that it was identified that the top foam was adhered to the tyvek lid, which resulted in the implant being projected into the floor.Risk management file documents the estimated residual risk associated with the reported event.This event occurred during surgery.A non-clinically significant delay (less than 30mins) to surgery was reported which gives a severity score of 2.This device is used for treatment.Therefore, the severity score is in line with the risk file.Occurrence: 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 jun 9, 2020.Sales (jul 2017 to jun 2020) (most up to date sales data) = (b)(4).56 complaints were identified for this item number including (b)(4).(b)(4).The overall risk score is negligible.Corrective and preventive actions: issue evaluation ie-11839 has been raised to further investigate this issue.Health hazard evaluation hhe-2020-00082 has been raised to assess the risk of product which may exhibit the issue in the field.This hhe resulted in a no field safety corrective action decision.There has been no increase in severity or occurrence since this hhe was completed.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported that when the foam lying on the oxford implant was removed, the implant stuck to the foam and fell to the floor.The surgery was completed by using the same item having another lot number.

Manufacturer Narrative

(b)(4).G3: report source, foreign - event occurred in germany.Products have been returned to biomet uk ltd for evaluation and forwarded to the complaints product evaluation engineer for investigation.The event reports that it was identified that that the top foam was adhered to the tyvek lid, which resulted in the implant being projected into the floor.This event occurred during surgery.A non-clinically significant (5mins) delay to surgery was reported.The surgery was completed with an alternative implant with the same item number.The complaint has been confirmed following review of the returned packaging, which has evidence to suggest that the top foam was adhered to the tyvek lid (transfer of material between the top foam and the tyvek lid).A review of the device history records did not identify any discrepancies that would have contributed to the reported event.A complaint history review identified 3 similar complaints for the same item number.A complaint history review identified no similar complaints for the same lot number.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.The ifu provided with the device states to check the packaging for damage before use.The likely condition of the device when it left zimmer biomet is non-conforming to specification.The correct packaging materials and sealing methods have been used.The likely cause of the reported event is not enough clearance between the top foam and the tyvek lid during the heat sealing process.This causes unintended heat transfers between the top foam and the tyvek lid, resulting in adhesion.The indent in the top foam (which have been caused by compression from the device) further indicate that the space within the blister would have been limited.Risk assessment: the event reports that it was identified that that the top foam was adhered to the tyvek lid, which resulted in the implant being projected into the floor.Risk management file documents the estimated residual risk associated with the reported event.This event occurred during surgery.A non-clinically significant delay (30mins +) to surgery was reported which gives a severity score of 2.This device is used for treatment.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 jun 9, 2020.Sales (jul 2017 to jun 2020) (most up to date sales data) = 3,520,350.56 complaints were identified for this item number including (b)(4).Therefore, the calculated occurrence rate is 56:3,520,350 = 1:62,863.This gives an occurrence score of 1.The overall risk score is negligible.Issue evaluation (b)(4) has been raised to further investigate this issue.Health hazard evaluation (b)(4) has been raised to assess the risk of product which may exhibit the issue in the field.This hhe resulted in a no field safety corrective action decision.There has been no increase in severity or occurrence since this hhe was completed.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

During surgery: when the foam lying on the oxford implant was removed, the implant stuck to the foam and fell to the floor.The surgery was completed by using the same item having another lot number.

• Brand Name: OXFORD UNI TWIN-PEG FEMORAL MD
• Type of Device: OXFORD PKS HIGH FLEX TWIN PEG CEMENTED FEMUR - MEDIUM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10232930
• MDR Text Key: 198600737
• Report Number: 3002806535-2020-00302
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 166942
• Device Lot Number: J6727309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1