MAUDE Adverse Event Report: AESCULAP AG AS TIBIA OFFSET STEM D12X52MM CEMENTED; KNEE ENDOPROSTHETICS

Model Number	NR191Z
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference code nr072z, device name as columbus rev f tib.Offset, cement.T1+, serial number n/a, batch number 52250077, udi device identifier (b)(4), udi production identifier (b)(4), basic udi-di n/a, unit of use udi-di (b)(4), manufacturing date 2016-06-21.Ref.Code device name batch: nr003z as columbus rev f femur cemented f3l 52330403.Nr400z as nut f/femur extens.Stem all sz.Neutr.52337135.Nr291z as femur extens.Stem 6° d12x77 cemented 52217431.Nr191z as tibia offset stem d12x52mm cemented 52337492.Nr614m columbus rev f hc glid.Surf.T1/1+ 18mm 52136849.Investigation no product at hand.Therefore an investigation at the device is not possible.Pictorial documentation: 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 for this topic (loosening) a product safety case (psc) was initiated.
Event or Problem Description
It was reported that there was an issue with as columbus knee.It was reported that as a result of having the product implanted, the patient has experienced knee pain, swellling, difficulty walking and loosening of the device.The primary procedure occurred on an unspecified date, and the revision was performed on (b)(6) 2017.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components: nr003z (ps femur cemented f3l).Nr400z (femur stem nut all sizes neutral).Nr291z (femoral stem cemented 6° neut d12x77mm).Nr072z (ps tibia cemented t1+).Nr191z (tibial offset stem cemented d12x52mm).Nr614m (ps hc pe insert t1/t1+ 18mm).The cement used is unidentified.The adverse event / malfunction is filed under reference (b)(4).Associated medwatches: 2916714-2020-00465, 2916714-2020-00466, 2916714-2020-00467, 2916714-2020-00468, 2916714-2020-00470.

• Brand Name: AS TIBIA OFFSET STEM D12X52MM CEMENTED
• Common Device Name: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10679348
• Report Number: 2916714-2020-00469
• Device Sequence Number: 2990886
• Product Code: HRY
• UDI-Device Identifier: 04046963176105
• UDI-Public: 4046963176105
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: NR191Z
• Device Catalogue Number: NR191Z
• Device Lot Number: 52337492
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/25/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention