MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN OXFORD TIBIAL COMPONENT

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Refer to attached journal article: tarek ahmed aly et al - "the oxford unicompartmental knee prosthesis: midterm follow-up" report source, foreign - events occurred in (b)(6).As limited information was received from the customer, the reported events could not be confirmed.As the lot numbers of the devices are unknown, dhr reviews could not be performed.Root cause could not be determined.If further information is found that would change or alter any conclusions reached, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor trends and react accordingly.The manufacturer did not receive x-rays, or other source of documents for review.As no lot number was provided for the device, the device history records could not be reviewed.At zimmer biomet (legal name of the site) all medical devices prior release to market undergo several quality inspections as defined in our quality procedures.Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold.These procedures are part of the overall quality management system at zimmer biomet and get regularly audited by our notified body, competent authorities and internal and external auditors.Thus, for all products sold to the market can be assumed having a complete and correct dhr.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Refer to attached journal article: "the oxford unicompartmental knee prosthesis: midterm follow-up" the following complaints were open and reported as a result of this journal: refer to attached journal article: "the oxford unicompartmental knee prosthesis: midterm follow-up" the following complaints are related to the journal: (b)(4) (3002806535 -2018 -00246), (b)(4) (3002806535 - 2018 -00249) , (b)(4) (3002806535 -2018 -00260, 3002806535 -2018 -00261, 3002806535 -2018-00262) zimmer biomet's reference number of this file is (b)(4).

Event Description

It was reported in a journal article two cases of a flexion lag because of mild flexion contracture treated with mobilization under anesthesia source: "the oxford unicompartmental knee prosthesis: midterm follow-up" by aly t.A., et al.(2010) abstract background unicompartmental knee arthroplasty is a relatively conservative form of replacement arthroplasty in that it preserves all the important stabilizing structures of the knee instead of discarding them.Our long-term results obtained with the oxford unicompartmental knee prosthesis (oukp) for medial unicompartmental knee osteoarthrosis are presented.Methods forty-five prostheses in 43 patients were evaluated using the hospital for special surgery (hss) knee score after 10 years (mean follow-up, 8 years 9 months).Three patients were lost to follow-up because of death.Results the mean hss score was 177.6 (80% excellent, 10% good, 5% fair, 5% poor).Conclusions these findings confirm the good results reported in other studies, regarding proper patient selection and a consistent operative technique.This complaint refers to the two cases of a flexion lag because of mild flexion contracture treated with mobilization under anesthesia.

• Brand Name: UNKNOWN OXFORD TIBIAL COMPONENT
• Type of Device: UNKNOWN OXFORD TIBIAL COMPONENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7279782
• MDR Text Key: 100413272
• Report Number: 3002806535-2018-00250
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention