MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FM HD 036/+4MM 12/14; CERAMIC FEMORAL HEAD PROSTHESIS

Model Number N/A

Device Problems Labelling, Instructions for Use or Training Problem (1318); Device Markings/Labelling Problem (2911)

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

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet in (b)(6) 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 during initial surgery it was discovered that the biolox etching information did not match the packaging which was labelled item # 650-0838, lot # 2020011040.No delay to surgery occurred.The product used to complete the surgery was item # 650-0838, lot # 2020021587.

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 valencia where hhe-2020-00238 has been raised to investigate incorrect biolox® delta modular ceramic head in packaging.The hhe describes the event as: on june 19, 2020, biomet 3i dental ibérica (b3i di) regulatory compliance team is informed by united kingdom complaint handling unit (uk chu) that there is one (1) complaint in which the reported event could be related to a possible mixed batch for ceramic heads.The information that states on the complaint as product information is item# 650-0838 and lot# 2020021587 which corresponds to a biolox® delta modular ceramic head 36mm +4mm, but when the item is open it is observed that the piece is engraved with an s.The reference 650-0838 should be engraved with an l and the s corresponds with the reference (b)(4).In the complaint appears also a label corresponding to an item# 650-0838 and lot# 2020011040 and this lot appears also in the complaint description.A clarification has been requested to uk chu in order to determine which is the alleged involved lot (2020011040 or 2020021587).On jun 25, 2020, b3i di regulatory compliance team received confirmation of the lot involved in the event (photos provided by deutschland gmbh complaint handling unit) in which is shown a labelling of a biolox® delta modular ceramic head 36mm +4mm (item # 650-0838 and lot# 2020011040) together with a biolox® delta modular ceramic head engraved with 36 12/14 s and serial number (b)(6).In additional, sales representative confirmed that the lot 2020021587 was used to proceed with the surgery.According to the labelling received, the item involved in the event corresponds to a biolox® delta modular ceramic head 36mm +4mm neck 12/14 taper (ref.(b)(4), lot 2020011040), but the item inside corresponds to biolox® delta modular ceramic head 36mm -4mm neck 12/14 taper.According to the product specification, the biolox® delta modular ceramic head 36mm +4mm neck 12/14 taper (ref.(b)(4)) is engraved with the description 36 ¿ 12/14 l and the biolox® delta modular ceramic head 36mm -4mm neck 12/14 taper (ref.(b)(4)) is engraved with the description 36 ¿ 12/14 s.Therefore, the item corresponds to biolox® delta modular ceramic head 36mm -4mm neck 12/14 taper (ref.(b)(4)) engraved with the description 36 ¿ 12/14 s and serial number (b)(6) and label corresponds to a biolox® delta modular ceramic head 36mm +4mm neck 12/14 taper (ref.(b)(4)).Visual examination of the product shows product to be non-conforming.Product hold ph-2020-00209 was initiated on 25th jun 2020.Risk assessment: a review of the complaint database over the last 3 years has found no similar complaints found for the item # 650-0838.Potential effect(s) of failure: insert not match with part/customer complaint.Potential causes: operator obtain incorrect material.Severity: 4 critical.Probability of occurrence: 2 rare ((b)(4)).Detectability (dia) 3 low.Corrective and preventive actions: capa ca-05797 was raised to identify the root cause.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during initial surgery it was discovered that the biolox etching information did not match the packaging which was labelled item # 650-0838, lot # 2020011040.No delay to surgery occurred.The product used to complete the surgery was item # 650-0838 lot # 2020021587.

• Brand Name: DELTA CER FM HD 036/+4MM 12/14
• Type of Device: CERAMIC FEMORAL HEAD PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10270052
• MDR Text Key: 201888788
• Report Number: 3002806535-2020-00321
• Device Sequence Number: 1
• Product Code: LZO
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-0838
• Device Lot Number: 2020011040
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1