MAUDE Adverse Event Report: BIOMET UK LTD. BI-POLAR 28 CUP 55MM; BIPOLAR FRACTURE HEADS

Model Number N/A

Device Problems Product Quality Problem (1506); Use of Device Problem (1670); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 remains implanted.Occupation: quality and regulatory leader at zimmer biomet.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the hospital that an expired product bi-polar 28 cup item # 165234 / lot # 3709176 was implanted on (b)(6) 2021.The product was in consignment and it was not sent back to zimmer biomet.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.It was reported that a patient underwent a hip arthroplasty, subsequently during the procedure an expired bi-polar cup was implanted.Research department has been asked to provide comments on the reported event: it was reported to zimmer biomet that the hospital reported that an expired product bipolar 28 cup item # 165234 / lot # 3709176 was implanted on (b)(6) 2021.As determined from the component packaging stickers, the component in question has an expiry date of 23 december 2020.Therefore at the time of implantation on (b)(6) 2021, it had exceeded its 5 year shelf life by approximately 1 month.Bi-polar acetabular cups comprise of a cocr shell, uhmwpe insert and uhmwpe ring.The stability of cocr has been confirmed for 10 years, and the 5 year shelf life for this device is based on the uhmwpe components.The primary concern of exceeding the 5 year shelf life is an increased risk of oxidative degradation of uhmwpe resulting from diffusion of oxygen into the packaging.This can lead to reactions with residual free radicals that are present in the material due to the gamma sterilisation process, with a subsequent change in the physical, mechanical and chemical properties of the material.In the absence of oxygen, these free radicals have nothing to react with and therefore the properties of the material are preserved.Any increase in oxidation may lead to an increased risk of wear and a decrease in mechanical properties, wear particle mediated osteolysis and loosening and fracture, respectively.Bi-polar acetabular cups are packaged using contemporary barrier packaging, which incorporates a glass film interposed between polymer sheets, acting as an oxygen barrier.The packaging is argon-flushed and then vacuum sealed to remove any residual oxygen that might otherwise react with residual free radicals remaining after gamma sterilisation of the component.The use of this packaging reduces the aforementioned risks dramatically.A study of contemporary orthopaedic packaging by the university of torino measured oxidation levels in expired and not-expired polyethylene components.It confirmed that little evidence of oxidation was found in uhmwpe stored within foil and polymer based-based barrier packaging, and that there was little difference in these results for when the packaging was expired or non-expired.While the bi-polar packaging does not incorporate foil in its packaging, it does have an impermeable glass layer designed to resist oxygen diffusion.The 5 year shelf-life of uhmwpe was initially predicated on the ability of the package to maintain sterility, and a consensus practice of 5-year shelf life was adopted in europe for medical implants so that sterility could be assured.In 1998, in the safety notice 9816¿1998 (uhmwpe components of joint replacement implants), the british medical devices agency established that uhmwpe components should not be used if they are over five years old and if they have passed their indicated expiry date; however this was in relation to implants that had been gamma sterilized in air and stored in air.To date, no similar warning has ever been issued by the food and drug administration in the united states or national regulatory bodies in other countries, for components sterilised and packed either in air, or in an inert atmosphere.The european committee for standardization (cen) attempted, but was ultimately not successful, in establishing standards that limit the shelf life of uhmwpe components to 5 years.Furthermore, the uhmwpe components in the bi-polar acetabular cup are manufactured using isostatic compression moulding (icm).Studies have demonstrated that icm polyethylene displays improved oxidation and wear resistance compared with alternative polyethylene moulding processes.Therefore, while there is a theoretical risk that the uhmwpe insert and ring within the bi-polar acetabular cup in (b)(4) will display a higher level of oxidation than a component still within its shelf life, this risk is expected to be negligible due to the argon-flushed, vacuum sealed, glass-lined packaging used for bipolar components and the icm process used to manufacture the uhmwpe polyethylene moulding processes.Therefore, while there is a theoretical risk that the uhmwpe insert and ring within the bi-polar acetabular cup in (b)(4) will display a higher level of oxidation than a component still within its shelf life, this risk is expected to be negligible due to the argon-flushed, vacuum sealed, glass-lined packaging used for bipolar components and the icm process used to manufacture the uhmwpe components.Moreover, any risks are outweighed by those associated with carrying out a component exchange procedure or revision surgery.Ultimately, it should be stated that the decision to monitor the performance of the device or to revise it rest with the treating surgeon." the hospital reported that expired product has been implanted.It should be noted that all biomet implants have clearly stated expiry date on their labels and this is the hospital's responsibility to check the expiry date before implantation.A review of the manufacturing history records confirms no abnormalities or deviations reported.Device is used for treatment.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Review of complaint history for the past 3 years found no additional related issues for this item, and the reported part and lot combination.Medical records were not provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.Risk assessment: risk management documents the estimated residual risk associated with the bi-polar acetabular system.Complaint summary states: there is a theoretical risk that the uhmwpe insert and ring within the bi-polar acetabular cup in (b)(4) will display a higher level of oxidation than a component still within its shelf life, this risk is expected to be negligible due to the argon-flushed, vacuum sealed, glass-lined packaging used for bipolar components and the icm process used to manufacture the uhmwpe components.Moreover, any risks are outweighed by those associated with carrying out a component exchange procedure or revision surgery.The reported event states that the expired product was implanted.This hazard (knowledge based failure - willful / accidental misuse or no indication of implant shelf life) has a severity of 4 which is described in the severity table as: life threatening or results in permanent impairment of a body function or permanent damage to a body structure.The outcome of this complaint is considered to be within the severity of 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 years prior to the notification date, being january 2021.Between january 2018 to january 2021 no other complaints were identified for this item number other than (b)(4).Occurrence rate assessment: 19 january 2018 to date of notification, 19 january 2021: (b)(4) items were sold.Therefore, the calculated occurrence rate is (b)(4).Since the occurrence calculation is based on only (b)(4) item sales, the current occurrence ratings in the risk management file are still relevant and have not been exceeded; as it is not possible to make a meaningful calculation based on (b)(4) item sales.The failure mode will be monitored through zimmer biomet¿s internal complaint and post market surveillance activities with further review of risk conducted through these processes.

Event Description

The expired product bi-polar 28 cup item # 165234 / lot # 3709176 was implanted in error.The use by date on label in the mhr is 2020-12-23 ( dec 23, 2020).It has been reported that a list of expired products were sent to the hospital and sales reps.In this case, the expired implant was never sent back to the warehouse.The surgeon mistakenly selected the expired product which he implanted on (b)(6) 2021.

• Brand Name: BI-POLAR 28 CUP 55MM
• Type of Device: BIPOLAR FRACTURE HEADS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11271612
• MDR Text Key: 230020920
• Report Number: 3002806535-2021-00027
• Device Sequence Number: 1
• Product Code: JDI
• 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,other
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/23/2020
• Device Model Number: N/A
• Device Catalogue Number: 165234
• Device Lot Number: 3709176
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other