MAUDE Adverse Event Report: AESCULAP AG AS FEMUR EXTENS.STEM 5 D16X117 CEM.LESS; KNEE ENDOPROSTHETICS

Model Number NR406Z

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

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 product as femur extens.Stem.Patient received a non-aesculap implant in the primary surgery.Due to implant failure, patient underwent a revision surgery and received an as columbus revision knee system implant.After the revision surgery, patient continued to experience left knee pain.Patient underwent an unspecified subsequent surgery on the left knee, which resulted in a revision surgery.The primary surgery occurred on (b)(6) 2014 for the non-aesculap surgery and the first revision surgery occurred on (b)(6) 2014; and the follow up revision surgery occured (b)(6) 2016.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components nr576z (ps femoral augment posterior f6 10mm).Nr406z (femoral stem cementless 5° neut d16x117mm).Nr076z (ps tibia cemented t3+).Nr176z (tibial offset stem cementless d16x92mm).Nr006z (ps femur cemented f6 l).Nr400z (femur stem nut all sizes neut).Nr132m (ps mc pe insert t3/t3+ 14mm).The cement used during the first revision surgery is biomet cobalt hv bone cement (402283).The first revision surgery was to replace a competitor component, the second revision was to replace an aesculap component.The adverse event / malfunction is filed under reference (b)(4).Associated medwatches: 2916714-2020-00261, 2916714-2020-00262, 2916714-2020-00259.

Event Description

No updates.Associated medwatches: 2916714-2020-00260; 2916714-2020-00261; 2916714-2020-00262; 2916714-2020-00259.

Manufacturer Narrative

Manufacturing site evaluation: internal notification number: 100025823 -> 400477306/400477307/400477308/400477309.Device reference code nr076z device name as columbus rev f tib.Offset zement.T3+ serial number n/a batch number 51949965 udi device identifier (b)(4).Udi production identifier (b)(4).Basic udi-di n/a unit of use udi-di (b)(4).Manufacturing date 2013-06-14.Ref.Code device name batch nr576z as columbus rev fem.Spacer post.F6 10mm 51939417; nr406z as femur extens.Stem 5° d16x117 cem.Less 51891612; nr176z as tibia offset stem d16x92 cementless 51888446.No product at hand.Therefore an investigation at the device is not possible.There are no pictures available.Batch history review the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Explanation and rationale in the light of the little information received and due the circumstance that we did not received the complained devices it is not possible to determine a root cause for the mentioned failure.Corrective action this case is concerning implant loosening.For this topic (loosening) a product safety case (psc) was initiated.

• Brand Name: AS FEMUR EXTENS.STEM 5 D16X117 CEM.LESS
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10315683
• MDR Text Key: 204407296
• Report Number: 2916714-2020-00260
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

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 Model Number: NR406Z
• Device Catalogue Number: NR406Z
• Device Lot Number: 51891612
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/09/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention