MAUDE Adverse Event Report: BIOMET UK LTD. 36MM 12/14 TPR FEM HD STD NK; METALLIC FEMORAL HEAD PROSTHESIS

Model Number N/A

Device Problems No Device Output (1435); Appropriate Term/Code Not Available (3191)

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

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that when inspecting the inner cone of the metal head before placing the head on the shaft cone, irregularities in the area of the cone surface were noticed that would otherwise not occur in this form.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.G3: report source, foreign - event occurred in (b)(6).D10: we have contacted the hospital requesting further information about the product (e.G.Requested product return).However, we have not received any response from the hospital regarding the product location.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 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.Trend identified as both complaints are from same hospital but different lot.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: 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 irregularities in the area of the cone surface.The severity is 4 : 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 therefore is in line with the rmf.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 calendar years prior to event 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 (b)(4).2 complaints were identified for this item number including (b)(4).(b)(4).If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : unknown location of the device.

Event Description

It was reported that when inspecting the inner cone of the metal head before placing the head on the shaft cone, irregularities in the area of the cone surface were noticed that would otherwise not occur in this form.

Manufacturer Narrative

(b)(4).This final/follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, g7, h1, h2, h3, h6, h10.G3: report source, foreign - event occurred in germany.The product was returned for evaluation and the evaluation results are as follows: the device has been visually inspected and found to be conforming to specification.See full investigation below: the event reports that the taper of the head is visually not as expected.This event occurred during surgery.No further information has been provided.The complaint has not been confirmed following review of the returned implant, which confirmed the device is conforming to specification.Visual examination confirms the implant is visually conforming to both the in-process inspection specification (i001485 rev 1, final polish metal femoral heads) and the final inspection specification (sop092 rev 4, in-process and final inspection).The visual inadequacies identified in the reported event are likely to be chatter marks which are only visible under lighting of a luminous intensity above that of the in process and final inspection requirements.The returned implant was viewed according to procedure (sop092), using normal/corrected vision under good lighting conditions, (light meter placed on the inspection bench reading of between 1000 & 1500 lux at arm length (typically between 12¿18), and the chatter marks are not identifiable.Therefore, the implant is conforming to specification.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 one similar complaints for the same item number.This complaint was from the same surgeon with the same notification date, but a different lot.A complaint history review identified no similar complaints for the same lot number.The severity of the reported event is in line with this risk file.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.The condition of the device when it left zimmer biomet is conforming to specification.The reported event has not been confirmed following evaluation of the returned device, which confirmed the implant is acceptable.No corrective action has been initiated as the reported event has not been confirmed.Risk assessment: a)severity assessment : this event occurred during surgery.No further harm was reported.This gives a severity score of 2, potential for extended surgery time while a new implant was located.The actual severity score is in line with the risk file.B)occurrence assessment: an occurrence assessment is not required as the reported event has not been confirmed.C)risk score: risk score not required at the reported event has not been confirmed.D)risk assessment summary: the severity of the reported event is in line with this risk file.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported that when inspecting the inner cone of the metal head before placing the head on the shaft cone, irregularities in the area of the cone surface were noticed that would otherwise not occur in this form.

• Brand Name: 36MM 12/14 TPR FEM HD STD NK
• Type of Device: METALLIC FEMORAL HEAD PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 9893180
• MDR Text Key: 219546884
• Report Number: 3002806535-2020-00184
• Device Sequence Number: 1
• Product Code: HRY
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 650-0888
• Device Lot Number: 2476274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1