MAUDE Adverse Event Report: AESCULAP AG COLUMBUS REV F MC GLID.SURF.T3/3+ 20MM; KNEE ENDOPROSTHETICS

Model Number NR135M

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 07/26/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with nr135m - columbus rev f mc glid.Surf.T3/3+ 20mm.According to the complaint description, there was a revision surgery for poly swap.Patient had returned to full activity and dislocated the tka with the femur jumping the ps post.The surgeon removed the mc poly and replaced it with a hc poly of the same thickness.A revision surgery was necessary.Additional information has been requested but not yet received as of this report.The adverse event is filed under aag reference (b)(4).Involved components: nr410z - as femur extens.Stem 5° d20x117 cem.Less - lot 52574825.Nr400z - as nut f/femur extens.Stem all sz.Neutr.- lot 52606425.Nr465z - as columbus rev fem.Spacer dist.F5 5mm - lot 52535726.Nr076z - as columbus rev f tib.Offset cement.T3+ - lot 52464853c.Nr177z - as tibia offset stem d17x92 cementless - lot 52591752.Nr565z - as columbus rev fem.Spacer post.F5 5mm - lot 52533878.Nr015z - as columbus rev f femur cemented f5r - lot 52571435.

Manufacturer Narrative

As of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.Rt.

Event Description

Involved components: nr410z - as femur extens.Stem 5° d20x117 cem.Less - lot 52574825, nr400z - as nut f/femur extens.Stem all sz.Neutr.- lot 52606425, nr465z - as columbus rev fem.Spacer dist.F5 5mm - lot 52535726, nr076z - as columbus rev f tib.Offset cement.T3+ - lot 52464853c, nr177z - as tibia offset stem d17x92 cementless - lot 52591752, nr565z - as columbus rev fem.Spacer post.F5 5mm - lot 52533878, nr015z - as columbus rev f femur cemented f5r - lot 52571435.

• Brand Name: COLUMBUS REV F MC GLID.SURF.T3/3+ 20MM
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12350184
• MDR Text Key: 267546196
• Report Number: 2916714-2021-00163
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 04046964009297
• UDI-Public: 4046964009297
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2021,12/14/2021

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 Expiration Date: 02/28/2023
• Device Model Number: NR135M
• Device Catalogue Number: NR135M
• Device Lot Number: 52419515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2021
• Distributor Facility Aware Date: 07/26/2021
• Device Age: 40 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NR015Z - LOT 52571435; NR015Z - LOT 52571435; NR076Z - LOT 52464853C; NR076Z - LOT 52464853C; NR177Z - LOT 52591752; NR177Z - LOT 52591752; NR400Z - LOT 52606425; NR400Z - LOT 52606425; NR410Z - LOT 52574825; NR410Z - LOT 52574825; NR465Z - LOT 52535726; NR465Z - LOT 52535726; NR565Z - LOT 52533878; NR565Z - LOT 52533878; NR015Z - LOT 52571435; NR076Z - LOT 52464853C; NR177Z - LOT 52591752; NR400Z - LOT 52606425; NR410Z - LOT 52574825; NR465Z - LOT 52535726; NR565Z - LOT 52533878
• Patient Outcome(s): Required Intervention