MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK BROACH

Catalog Number UNK BROACH

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

Patient Problems Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)

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

Literature article entitled: ¿literature received entitled: " direct, cementless, metaphyseal fixation in knee revision arthroplasty with sleeves-short-term results" written by heiko graichen, md et al., published: the journal of arthroplasty 30(2015) 2256¿2259, was reviewed for mdr reportability on 10/01/2019.The purpose of the article was to analyze the short- and mid-term results of sleeve-fixation in a large revision tka series.In the prospective study 121 patients with 193 sleeves (119 tibial and 74 femoral).In all cases the depuy pfc sigma mobile bearing revision tibial tray was used.In 77 patients, a posterior stabilized insert was used, in 27 a tc3 insert (vvc constraint), and in 17 a rotating hinge was implanted.Intraoperative complications included two fractures of the anterior, distal cortex of femur during femoral broaching.Postoperative complications included stem pain on the femoral stem tip (1.4%) and one patient with tibial stem pain a loosening of the tibial implant was noted during a later revision.4 patients have been revised to address pain and aseptic loosening.There were 14 revisions were performed.Four of those revisions were for infection.Three revision were for ligament instability, one was for malalignment and one revision was for extensor mechanism failure.There were two revisions for fracture of the implant at the junction between the stem and sleeve.Both of those cases showed insufficient osseo-integration of the sleeve in combination with malalignment and excellent stem fixation leading to low stress high cycle fatigue.The conclusion of the article noted that the cementless metaphyseal fixation with the use of sleeves is a promising option for revision tka implant fixation.

Manufacturer Narrative

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: UNK BROACH
• Type of Device: BROACH
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9211125
• MDR Text Key: 162974612
• Report Number: 1818910-2019-109506
• Device Sequence Number: 1
• Product Code: HTQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK BROACH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention