MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN KNEE FEMORAL SLEEVE; UNK KNEE FEMORAL SLEEVE

Catalog Number UNK KNEE FEMORAL SLEEVE

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)

Patient Problems Bone Fracture(s) (1870); Not Applicable (3189); No Code Available (3191)

Event Date 11/28/2019

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.

Event Description

During use on a patient: the surgeon decided to use tc3 with a plan to convert to an s-rom hinge if there was instability of the mcl.The tc3 was sufficient to cope with the instability.The surgeon initially planned for an uncemented femoral sleeve 31mm, however this was too big for the canal and may have caused a fracture on the anterior surface of the femur.The surgeon changed to a cemented 20mm sleeve and chose to use a 10mm press fit stem cemented in.It was discussed that he should use a cemented stem within licence, but due to a small femoral canal, felt that he could not ream any further to achieve a sufficient cement mantle.Upon cementing the surgeon decided that he should cable the fracture.2 cables were used to secure the fracture.

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 (device).Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.The complaint was received into the company with the following comment: during use on a patient: the surgeon decided to use tc3 with a plan to convert to an s-rom hinge if there was instability of the mcl.The tc3 was sufficient to cope with the instability.The surgeon initially planned for an uncemented femoral sleeve 31mm, however this was too big for the canal and may have caused a fracture on the anterior surface of the femur.The surgeon changed to a cemented 20mm sleeve and chose to use a 10mm press fit stem cemented in.It was discussed that he should use a cemented stem within licence, but due to a small femoral canal, felt that he could not ream any further to achieve a sufficient cement mantle.Upon cementing the surgeon decided that he should cable the fracture.2 cables were used to secure the fracture.No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The reported event is considered one of the possible complications of joint replacement.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.The device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicates that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed.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 KNEE FEMORAL SLEEVE
• Type of Device: UNK KNEE FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9527220
• MDR Text Key: 173445830
• Report Number: 1818910-2019-124834
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/28/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL SLEEVE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 02/04/2020
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR