MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DEPUY/CMW 2G; BONE CEMENT : BONE CEMENT

Catalog Number 545032500

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 11/19/2019

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

Patient was revised to address pain and loosening of the tibial baseplate at the cement to implant interface.Depuy cement manufacturer was used.Patient presented with anterior tibial knee pain to the surgeon and has been unpleased with the primary prosthesis since original placement.Surgeon determined tibial baseplate was likely loose based off of pre-operative images.It was determined intra-operatively that the tibial baseplate was likely aseptically loose, however it took several minutes to remove the baseplate from the tibia bone.Baseplate appeared wet and fatty from micro-lipid infiltration between the implant and cement.Tibia baseplate did not have cement attached to the prosthesis.Surgeon decided to revise the femur, tibia and insert to attune revision to achieve a higher level of stability.Neither the femur nor patella showed signs of loosening.Patient requested for primary attune implants be collected for potential litigation.Doi: (b)(6) 2016; dor: (b)(6) 2019 left knee.

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.Product complaint#: (b)(4).Investigation summary: the device associated with this report was not received for examination.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.Device history lot: 8312417.Device history batch: null.Device history review: a device history record (dhr) review was conducted as part of investigation (b)(4).The dhr review found no non-conformances on this batch.Final micro and sterility tests passed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

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.Additional narrative: product complaint # (b)(4).Investigation summary the device associated with this report was not received for examination.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.Device history lot
=
> 8312417.Device history review a device history record (dhr) review was conducted as part of investigation (b)(4).The dhr review found no non-conformance's on this batch.Final micro and sterility tests passed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DEPUY/CMW 2G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 9453035
• MDR Text Key: 185106814
• Report Number: 1818910-2019-122498
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174271
• UDI-Public: 10603295174271
• Combination Product (y/n): N
• PMA/PMN Number: K061144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 545032500
• Device Lot Number: 8312417
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE PS FEM LT SZ 6 NAR CEM; ATTUNE PS RP INSRT SZ 6 7MM
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR