MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFC*SIGMA/OV/DOME PAT 3PEG,41; SIGMA KNEE PRIMARY : KNEE PATELLA

Catalog Number 960103

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Irritation (1941); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Discomfort (2330); Joint Swelling (2356)

Event Date 11/09/2016

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(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

Clinical der states ae for a questionable loose patellar component.The ct is suggestive of loosening.On 01/31/2017--x-ray images received on disc (x1) sm.Update rec'd 01/31/2017 - the patient's medical records were received.Medical records were reviewed for mdr reportability.At this time there is no new information that would change the existing mdr decision.The complaint was updated on: 02/13/2017.Update 4/18/2017 - medical records received.Office notes indicate right knee intermittent pain and discomfort; recurrent effusion, suggestive of hemarthrosis, and x-rays, followed by a ct scan, suggest fragmentation of the cement mantle with probable right patellar implant loosening.Currently, the cement is unknown for purposes of manufacturer and therefore will not be reported.It is also unclear at present if there has been a loosening between the patella and cement mantle interface, and/or the cement to bone interface.There is no new information that would change the existing mdr decision.This complaint was updated on 5/9/2017.Update 4/24/2017 - clinical der received.Right knee revised for hemarthrosis and instability, after ae received for right total knee patellar migration/loosening.Followup underway to determine whether loosening occured between implant and cement and/or cement and bone, as well as identification of the cement manufacturer.Dor updated and patella reported for implant migration, pain, discomfort, instability, and soft tissue irritation.This complaint was updated on 5/9/2017.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Review of the device history records did not reveal any related manufacturing deviations or anomalies on the reported product and lot combination.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.Update 01/31/2017- patient x-ray images and medical records received.Update (5/9/2017) dor: (b)(6) 2017.The new information does not change the existing investigation.Device history lot
=
> product code 960103, work order (b)(4).Device history review: (b)(4) parts were manufactured per specification and all raw materials met specification.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product event summary: the full lead was returned, analyzed, and no anomalies were found.Visual analysis of the lead indicated apparent explant damage.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Complaint description: clinical der states ae for a questionable loose patellar component.The ct is suggestive of loosening.(b)(6) 2017--x-ray images received on disc (x1) sm.Update rec'd 01/31/2017 - the patient's medical records were received.Medical records were reviewed for mdr reportability.At this time there is no new information that would change the existing mdr decision.The complaint was updated on: 02/13/2017.Update 4/18/2017 - medical records received.Office notes indicate right knee intermittent pain and discomfort; recurrent effusion, suggestive of hemarthrosis, and x-rays, followed by a ct scan, suggest fragmentation of the cement mantle with probable right patellar implant loosening.Currently, the cement is unknown for purposes of manufacturer and therefore will not be reported.It is also unclear at present if there has been a loosening between the patella and cement mantle interface, and/or the cement to bone interface.There is no new information that would change the existing mdr decision.This complaint was updated on 5/9/2017.Update 4/24/2017 - clinical der received.Right knee revised for hemarthrosis and instability, after ae received for right total knee patellar migration/loosening.Followup underway to determine whether loosening occured between implant and cement and/or cement and bone, as well as identification of the cement manufacturer.Dor updated and patella reported for implant migration, pain, discomfort, instability, and soft tissue irritation.This complaint was updated on 5/9/2017 / | investigation method: no device associated with this report was received for examination.A complaint database search on the provided pfc*sigma/ov/dome pat 3peg,41 (product code 960103, lot number 3308922) found an additional report and a dhr review was conducted.Dhr review (b)(4) (product code 960103, lot number 3308922) product code 960103, work order (b)(4) was manufactured on 13 may 2011.30 parts were manufactured per specification and all raw materials met specification.There were no ncs or deviations associated with this lot due to no similar failures found in the dhr review, the root cause of the complaint cannot be determined.Should further information come available that impacts the findings in this investigation it will be reopened.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.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.Update 01/31/17- patient x-ray images and medical records received.After review of the medical records and x-rays there are no changes required to the existing investigation.01/31/17--x-ray images received on disc (x1) sm.Update rec'd 01/31/2017 - the patient's medical records were received.Medical records were reviewed for mdr reportability.At this time there is no new information that would change the existing mdr decision.The complaint was updated on: 02/13/2017.Update 4/18/2017 - medical records received.Office notes indicate right knee intermittent pain and discomfort; recurrent effusion, suggestive of hemarthrosis, and x-rays, followed by a ct scan, suggest fragmentation of the cement mantle with probable right patellar implant loosening.Currently, the cement is unknown for purposes of manufacturer and therefore will not be reported.It is also unclear at present if there has been a loosening between the patella and cement mantle interface, and/or the cement to bone interface.There is no new information that would change the existing mdr decision.This complaint was updated on 5/9/2017.Update 4/24/2017 - clinical der received.Right knee revised for hemarthrosis and instability, after ae received for right total knee patellar migration/loosening.Followup underway to determine whether loosening occured between implant and cement and/or cement and bone, as well as identification of the cement manufacturer.Dor updated and patella reported for implant migration, pain, discomfort, instability, and soft tissue irritation.This complaint was updated on 5/9/2017./ | investigation summary: clinical der states ae for a questionable loose patellar component.The ct is suggestive of loosening.Doi: (b)(6) 2011 - dor: no revision (right knee).No device associated with this report was received for examination.A complaint database search on the provided pfc*sigma/ov/dome pat 3peg,41 (product code 960103, lot number 3308922) found an additional report and a dhr review was conducted.Review of the device history records did not reveal any related manufacturing deviations or anomalies on the reported lot number (3308922).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.Update 01/31/2017- patient x-ray images and medical records received.After review of the medical records and x-rays there are no changes required to the existing investigation.

• Type of Device: SIGMA KNEE PRIMARY : KNEE PATELLA
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; depuy orthopaedics, inc. 18189; warsaw 46582
• MDR Report Key: 6555158
• MDR Text Key: 74752560
• Report Number: 1818910-2017-17828
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: K961685
• 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: 12/22/2016

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: 960103
• Device Lot Number: 3308922
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/09/2017
• Supplement Dates Manufacturer Received: 01/25/2017; 01/25/2018
• Supplement Dates FDA Received: 01/26/2018; 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 93