MAUDE Adverse Event Report: BIOMET UK LTD. DELTA CER FM HD 028/+3.5 12/14; CERAMIC FEMORAL HEAD PROSTHESIS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 02/11/2020

Event Type  Injury  

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.Concomitant medical products: medical product: avan reld acet shl ss ha 50mm, catalog #: p0460p50, lot #: 0000759720, medical product: avan e1 insert 28 s 50, catalog #: p0561e50, lot #: 0000794937.(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a hip implant due to arthrosis.Subsequently, a revision surgery was performed due to excessive wear.The liner was completely worn and the head was articulating on the metal part of the cup.

Event Description

It was reported that the patient underwent a hip implant due to arthrosis.Subsequently, a revision surgery was performed due to excessive wear.The liner was completely worn and the head was articulating on the metal part of the cup.

Manufacturer Narrative

(b)(4).This final/follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g4, g7, h1, h2, h10.G3: report source, foreign - event occurred in italy.D4: further communication received from the per group in italy regarding the lot number (provided the correct lot no.:2133700).D11: medical product: avan reld acet shl ss ha 50mm, catalog #: p0460p50, lot #: 0000759720 medical product: avan e1 insert 28 s 50, catalog #: p0561e50, lot #: 0000794937.The mhr related to the involved product has been reviewed and does not show any non-conformity, rejection or concession that could be related to the reported event.All the lot (b)(4) units) was accepted at the time of manufacturing.No changes on the complaint outcome or the risk assessment.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.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Report source, foreign - event occurred in italy.D10: we contacted the hospital requesting product return.However, we have not received any respond and no product has been received.D11: medical product: avan reld acet shl ss ha 50mm, catalog #: p0460p50, lot #: 0000759720.Medical product: avan e1 insert 28 s 50, catalog #: p0561e50, lot #: 0000794937.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.One pre-revision anteroposterior (ap) radiograph was provided with (b)(4) for analysis, the date on which it was taken has not been provided.The biolox delta femoral head is articulating against the superior wall of the avantage acetabular cup, in agreement with the reported wear of the avantage e1 liner.The acetabular shell appears to be positioned at a high inclination angle.However, this cannot be confirmed without a full-pelvis ap x-ray due to the lack of bony landmarks for referencing.The relevant surgical technique states that the acetabular should be implanted at 40 to 45 degrees of inclination and 10 to 15 degrees of anteversion.Post-primary radiographs have not been received with (b)(4), and are required in order to assess the initial component sizing, positioning and alignment.Additionally, cerclage wire is visible around the patient femur, which was implanted around 3 years prior to revision to stabilise an oblique fracture distal to the stem.Details regarding this previous trauma have not been provided.It cannot be determined whether the trauma event or subsequent surgical intervention contributed in any way to the increased wear of the avantage e1 liner.The manufacturing history records (mhrs) for the avantage acetabular shell and avantage e1 liner have been checked and verify that the components were manufactured and sterilised in accordance with the applicable specifications.The mhrs for the biolox delta femoral head and gts femoral stem were not available at the time of writing this assessment and therefore could not be checked.The instructions for use provided with the avantage e1 liner provides the following information: 1) factors likely to compromise implant success and device performance: significant deformations, congenital dislocation.Ligament instability or serious and untreatable muscle contractures.Patient history of infections or repeated falls.Substance dependence.Poor positioning of insert in cup.Trauma possibly causing an implant to break.Poor orientation of cotyle.2) adverse reactions: wearing of the acetabular components polyethylene joint surfaces was observed following total hip replacement.Higher wear rates may be caused by particles of cement, metal or other debris that may lead to abrasion of joint surfaces.Significant wear may shorten the prosthesis useful life and lead to premature replacement of the prosthesis worn components.Dislocation or subluxation of prosthetic components due to improper positioning and/or migration of components can occur.Muscle and fibrous tissue laxity can also contribute to these conditions.Prosthetic components can come loose or migrate following trauma.At the time of writing this report, it is not possible to determine the root cause of revision without additional information such as surgical notes, postprimary x-rays, patient details (including activity level), and examination of the revised components.A review of the complaint database over the last 3 years has found no similar complaint for this item code 650-0832.Without the opportunity to examine the complaint product, the root cause cannot be determined due to insufficient information.Risk assessment: the event reports revision due to excessive wear.Risk management report documents the estimated residual risk associated with the reported event.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables assessed below could not be selected for comparison.Additionally, the reported event states the patient suffered a fall around three years prior to revision resulting in bone fracture.Line 3.1.2.7 of risk file relates to the reported event: excessive patient activity or postoperative trauma overloads the head.This line has a harm of non-functioning joint with a severity score of 3 which is defined in the rmr as: prescribed medical or surgical intervention to preclude permanent impairment of a body function or body structure.Contributed to minor, temporary, or medically reversible injury.The outcome of this complaint is considered to be within the severity of the rmr.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 (b)(6) 2020.Sales ((b)(6) 2017 to (b)(6) 2020) = (b)(4) units.Complaints search was conducted for events occurring between (b)(6) 2017 to (b)(6) 2020 for item 6500832.No other complaints were identified for this item number other than cmp0582358.Therefore, the calculated occurrence rate is 1 in 2003 or (b)(4).The hazard of excessive patient activity or postoperative trauma overloads the head nonfunctioning joint is documented in the risk file as 2: remote (b)(4).However, the occurrence in this case is calculated using a single complaint.Therefore, the current occurrence rating in the risk management file are still relevant and have not been exceeded; it is not possible to make a calculation based on one instance of a complaint.The failure mode will be monitored through zimmer biomet internal complaint and post market surveillance activities with further review of risk conducted through these processes.Corrective action taken: no corrective action required at this time.Preventive action taken: no preventive action required at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

It was reported that the patient underwent a hip implant due to arthrosis.Subsequently, a revision surgery was performed due to excessive wear.The liner was completely worn and the head was articulating on the metal part of the cup.

• Brand Name: DELTA CER FM HD 028/+3.5 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: 9804898
• MDR Text Key: 182534685
• Report Number: 3002806535-2020-00120
• 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,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-0832
• Device Lot Number: 2133700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2020
• 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