MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 5 PMA; KNEE ARTHROPLASTY

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported a product with expiration date 25.05.2021 was implanted (b)(6) 2021.

Manufacturer Narrative

(b)(4) this final report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, h1, h2, h6, h10.It has been reported that the implant was a part of loaner set and was verified that the receipt was scheduled for 24.05.2021 (one day before expiration date) then it should be replaced in local warehouse, but the hospital did not provide the package to the courier.Before another receipt was scheduled and completed, the hospital performed another procedure and used expired product.Research department has been asked to provide comments on the reported event: it was reported to zimmer biomet that the above device was implanted on (b)(6) 2021 and it was only later realised by the hospital that the device had expired on (b)(6) 2021.Therefore, at the time of implantation, it had exceeded its 5-year shelf life by 2 days.The primary concerns related to exceeding the 5-year shelf life with conventional ultra-high molecular weight polyethylene (uhmwpe) are (a) loss of sterility of the packaging and (b) increased risk of oxidative degradation resulting from diffusion of oxygen into the packaging.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 sterilized 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.The actual sterility period may actually be longer than five years, but real-time validation testing does not extend beyond this five-year period.Notably, this means that it also cannot be said that the sterility ends after the five years.Consequently, it is possible that an implant becomes non-sterile before the validated sterility period has passed due a damaged packaging but the sterility may also extend beyond this period (but this has not officially been validated).As result, we are not in a position to guarantee that the bearing was still sterile when implanted in the patient.On the other hand, if the patient has not developed any infection to date, this is a positive sign and may indicate that the bearing was indeed likely still sterile.Regarding the risk of oxidation of the polyethylene, oxford arcom bearings 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.Furthermore, oxford bearings are manufactured using direct compression moulding (dcm).Studies have demonstrated that dcm uhmwpe displays improved oxidation and wear resistance compared with alternative polyethylene moulding processes.In summary, while there is a theoretical risk that the bearing could be non-sterile, the absence of an infection (if this has been confirmed) would point to it being sterile.Similarly, the risk of oxidation is also expected to be negligible due to the bearing being manufactured direct compression moulded uhmwpe, with argon-flushed, vacuum sealed, glass-lined packaging.Moreover, it should be noted that any theoretical risks are outweighed by those associated with carrying out a revision surgery.Based on this, we would therefore not suggest that any additional action is required apart from your continued routine clinical monitoring of the patient involved in line with the normal protocols employed by the responsible clinician.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 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.

Event Description

It was reported a product with expiration date 25.05.2021 was implanted (b)(6) 2021.

• Brand Name: OXF ANAT BRG LT MD SIZE 5 PMA
• Type of Device: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11981724
• MDR Text Key: 255607937
• Report Number: 3002806535-2021-00254
• 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
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2021
• Device Model Number: N/A
• Device Catalogue Number: 159549
• Device Lot Number: 3805111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1