MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN UNICOMPARTMENTAL KNEE REPLACEMENT; UNKNOWN KNEE REPLACEMENT

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); No Information (3190)

Event Type  Injury  

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.(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

On 27-oct-2020, we received a journal article entitled, 'age stratified, matched comparison of unicompartmental and total knee replacement', by j.A.Kennedy, h.R.Mohammad, s.J.Mellon, c.A.F.Dodd, d.W.Murray et al.(2020).The aim of the study was to compare the functional outcome and failure rate of medial unicompartmental knee replacement (ukr) and total knee replacement (tkr) in different age groups.Various revision procedures and re-operations are listed in the publication for ukr cohort (series of 1000 consecutive phase 3 cemented oxford medial mobile-bearing ukr (zimmer biomet, warsaw, indiana) implanted in 818 patients) compared with patient matched tkr cohort (various).To ensure a fair comparison it was a requirement that the ukr were all implanted for the recommended indications and that they were matched to tkr that were also implanted in knees that were appropriate for ukr.Results are reported tkr vs ukr for ages <60, 60 to <75 and 75+.Median 10-year oks were 33 vs 45 (p < 0.001), 36 vs 42 (p < 0.001) and 36 vs 38 (p = 0.25).Ten-year revision rates were 11% vs 7%, 5% vs 5%, and 5% vs 10%, (none significant).The composite failures occurred 8%, 5% and 5% more frequently with tkr than ukr (none significant).Table 5 within the article details the various revision indication and outcomes by age groups and prosthesis, which reported failures for the ukr including: disease progression and dislocation.<60 : disease progression (lateral); dislocated bearing (bearing exchange and femoral component revision).60-75: disease progression × 3; bearing exchange (dislocation) × 2.75+: disease progression (lateral) × 2.Table 6 within the article details the various reoperations excluding revisions for the ukr including: arthroscopy and mua (manipulation under anaesthesia).<60: arthroscopy (pain) × 2; arthroscopy and washout (pain ¿ performed elsewhere); arthroscopy, and debridement (unspecified) × 2; mua (stiffness).60-75: arthroscopy × 5 arthroscopy and washout × 1 mua × 7 75+: mua (stiffness) × 2 in this matched study ukr provided better functional outcomes in all age groups, particularly the young, and provided substantially more excellent outcomes.Although in older groups tkr tended to have a lower revision rate, in the young ukr had a lower revision rate.This study supports the use of ukr with recommended indications, in all age groups.We cannot ascertain from the article exactly how many revisions and reoperations were studied for the ukr.There may be more than listed in table 5 & 6.Further information has been requested.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Follow-ups were sent to obtain more information about the affected device and supporting documentation (e.G.X-rays, surgical notes).As the product has not been received, the investigation was limited to the information provided.We have not been provided with x-rays or any supporting documentation which could provide additional information.The item number and lot number identification necessary to review manufacturing history and the complaint history was not provided.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.

Event Description

On 27-oct-2020, we received a journal article entitled age stratified, matched comparison of unicompartmental and total knee replacement by j.A.Kennedy, h.R.Mohammad, s.J.Mellon, c.A.F.Dodd, d.W.Murray et al.(2020).The aim of the study was to compare the functional outcome and failure rate of medial unicompartmental knee replacement (ukr) and total knee replacement (tkr) in different age groups.Various revision procedures and re-operations are listed in the publication for ukr cohort (series of 1000 consecutive phase 3 cemented oxford medial mobile-bearing ukr (zimmer biomet, warsaw, indiana) implanted in 818 patients) compared with patient matched tkr cohort (various).To ensure a fair comparison it was a requirement that the ukr were all implanted for the recommended indications and that they were matched to tkr that were also implanted in knees that were appropriate for ukr.Results are reported tkr vs ukr for ages <60, 60 to <75 and 75+.Median 10-year oks were 33 vs 45 (p < 0.001), 36 vs 42 (p < 0.001) and 36 vs 38 (p = 0.25).Ten-year revision rates were 11% vs 7%, 5% vs 5%, and 5% vs 10%, (none significant).The composite failures occurred 8%, 5% and 5% more frequently with tkr than ukr (none significant).Table 5 within the article details the various revision indication and outcomes by age groups and prosthesis which reported failures for the ukr including: disease progression and dislocation.<60 disease progression (lateral), dislocated bearing (bearing exchange and femoral component revision).60-75 disease progression × 3, bearing exchange (dislocation) × 2.75+ disease progression (lateral) × 2.Table 6 within the article details the various reoperations excluding revisions for the ukr including: arthroscopy and mua (manipulation under anaesthesia).<60 arthroscopy (pain) × 2, arthroscopy and washout (pain ¿ performed elsewhere), arthroscopy, and debridement (unspecified) × 2, mua (stiffness).60-75 arthroscopy × 5, arthroscopy and washout × 1, mua × 7.75+ mua (stiffness) × 2.In this matched study ukr provided better functional outcomes in all age groups, particularly the young, and provided substantially more excellent outcomes.Although in older groups tkr tended to have a lower revision rate, in the young ukr had a lower revision rate.This study supports the use of ukr with recommended indications, in all age groups.We cannot ascertain from the article exactly how many revisions and reoperations were studied for the ukr.There may be more than listed in table 5 & 6.

• Brand Name: UNKNOWN UNICOMPARTMENTAL KNEE REPLACEMENT
• Type of Device: UNKNOWN KNEE REPLACEMENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10910258
• MDR Text Key: 220906535
• Report Number: 3002806535-2020-00493
• Device Sequence Number: 1
• Product Code: HRY
• 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: other,study
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• 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: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2020
• 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