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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 5 PMA; KNEE PROSTHESIS
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BIOMET UK LTD. OXF ANAT BRG LT MD SIZE 5 PMA; KNEE PROSTHESIS Back to Search Results
Model Number N/A
Device Problem Migration (4003)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Concomitant medical products: medical product: oxf uni tib tray sz d lm pma, catalog #: 154724, lot #: 342130, medical product: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #: 800730, medical product: 1/8 quick rel drl sterile 2pk, catalog #: 32-486265, lot #: 765430, medical product: stryker op rcp 76.0x11.7, catalog #: 277325, lot #: 313706, medical product: stryk_76542k_13x90x.89f, catalog #: 13-0900-89y-f1, lot #: 313261.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2020-00035, 3002806535-2020-00036.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 an initial left knee arthroplasty.Subsequently, a revision procedure due to bearing dislocation was performed.
 
Event Description
It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2018.Subsequently, 1st revision was performed on (b)(6) 2019 and second revision was performed due to poly dislocation of bearing on (b)(6) 2019.This complaint reports the second revision performed on (b)(6) 2019.
 
Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.D11: medical product: oxf uni tib tray sz d lm pma, catalog #: 154724, lot #: 342130.Medical product: oxf twin-peg cmntd fem md pma, catalog #: 161469, lot #: 800730.Medical product: 1/8 quick rel drl sterile 2pk, catalog #: 32-486265, lot #: 765430.Medical product: stryker op rcp 76.0x11.7, catalog #: 277325, lot #: 313706.Medical product: stryk_76542k_13x90x.89f, catalog #: 13-0900-89y-f1, lot #: 313261.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.Two pre-revision radiographs, the same x-rays provided with (b)(4) (taken on an unknown date), were provided for analysis with (b)(4): one anteroposterior (ap) and one mediolateral (ml).One of the bearing¿s ball markers is visible in the ap x-ray, whereas the wire and a ball marker are visible in the ml x-ray, confirming that the bearing has dislocated into the anterior joint space.The femoral and tibial components appear adequately sized and positioned, with the possible exception of the tibial tray being short of the posterior edge of the tibial plateau.The oxford partial knee surgical technique states that the tibial tray should be flush with (or have less than 2 mm overhang from) the posterior edge of the tibial plateau.The patient is male and was 69 years old at the time of primary surgery.In communications with the complaints team, it is stated that there were no contributing conditions related to the event.The dislocation of the 6 mm bearing, which was implanted to replace a dislocated 5 mm bearing on (b)(6) 2019, suggests joint laxity.The left oxford partial knee was revised to a vanguard total knee on (b)(6) 2019.The cause for revision cannot be determined without further information such as patient height and weight, activity level, dates when the provided radiographs were taken, as well as x-rays from after primary surgery and the first revision surgery.The manufacturing history records (mhrs) for the femoral component, tibial tray and anatomical bearing have been checked and verify that the components were manufactured and sterilised in accordance with the applicable specifications.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the complaint database over the last 3 years has found 1 similar complaint found for the item 159550.There were no trends identified from the complaint history review.No same lot numbers, no same hospitals and there are no trends in cause.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.
 
Event Description
It was reported that a patient underwent an initial left knee arthroplasty on (b)(6) 2018.Subsequently, 1st revision was performed on (b)(6) 2019 and second revision was performed due to poly dislocation of bearing on (b)(6) 2019.This complaint reports the second revision performed on (b)(6) 2019.
 
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Brand Name
OXF ANAT BRG LT MD SIZE 5 PMA
Type of Device
KNEE PROSTHESIS
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK  CF31 3XA
MDR Report Key9615552
MDR Text Key175836083
Report Number3002806535-2020-00034
Device Sequence Number1
Product Code NRA
Combination Product (y/n)N
PMA/PMN Number
P010014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 04/22/2020
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? No
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number159549
Device Lot Number561850
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/27/2019
Initial Date FDA Received01/22/2020
Supplement Dates Manufacturer Received03/09/2020
04/20/2020
Supplement Dates FDA Received03/30/2020
04/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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