MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN ANKLE TIBIAL INSERT

Catalog Number UNK ANKLE TIBIAL INSERT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The literature article entitled ¿the effect of sagittal and coronal balance on patient-reported outcomes following mobile bearing total ankle replacement¿ written by sarah johnson-lynn et al., published in the journal of foot and ankle surgery, in 2018; was reviewed.The purpose of the article was to determine the relative importance of the pre- and post-tar coronal and sagittal balance on proms in the united kingdom population, and to determine whether the cause of ankle arthritis is associated with the degree of pre- or postoperative deformity.Depuy products used: the mobility total ankle system which includes a cobalt-chrome tibial component, a uhmwpe bearing insert and a cobalt-chrome talar component.The study was based on 101 tar¿s in 99 patients who participated in the minimum two-year follow-up.The study used radiographic assessment and statistical analysis.There were different groups for analysis¿an osteoarthritis group, a posttraumatic arthritis group and a rheumatoid arthritis group.They took different measurements pre and postoperatively which were the anterior distal tibial angle (adta); medial distal tibial angle (mtda); and the tibiotalar ratio (ttr).There were three revision surgeries during the follow-up period, although no further information was given regarding why.There were no significant differences between the groups.In conclusion, there were more patients with varus malalignment in the ptoa and oa groups and more valgus malalignment in the ra group, there was no significant difference in preoperative coronal and sagittal plane deformity between patients with ra, ptoa and oa.Moreover, there was no statistically significant correlation between preoperative deformity and postoperative function, as measured by the aofas hindfoot-ankle score.Faos.Or sf-36 scores.Furthermore, postoperative sagittal plane alignment did not correlate significantly with postoperative function, as measured by the aofas hindfoot ankle score, faos, or sf-36 scores.Finally, coronal plane alignment, as measured by the mdta, was significantly correlated with the postoperative aofas hindfoot-ankle score and the function subscale of the faos score.The faos still reported stiffness and pain in all groups.It was also noted that due to the short follow-up period, it cannot be determined if the influence of alignment impacts failure.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected:h6 product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN ANKLE TIBIAL INSERT
• Type of Device: ANKLE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9574362
• MDR Text Key: 185738182
• Report Number: 1818910-2020-01398
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

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 Catalogue Number: UNK ANKLE TIBIAL INSERT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention