MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COM POST AUG 5MM STD; LCS COMPLETE : KNEE FEMORAL ACCESSORY

Model Number	1294-27-040
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Hcp reported to (b)(4): "relative movement of the femoral shield.The epiphyseal zone is loosened and the plug cone to the metaphyseal sleeve shows distinct corrosion marks (fretting).Loosening of the femoral component after knee-tep-change in (b)(6) 2018.Knee-tep lcs revision on (b)(6) 2019; partially coupled, stalk guided, partially cemented.".
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional 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).The complaint products were transferred to depuy warsaw for investigation.Complaints databases searched on the augment product, lot 345878 identified no previous complaints.A review of the augment, product lot 345878 manufacturing records identified that 8 off products were finish manufactured 15-march-2013.No deviations or anomalies were found.The products had an expiry date of february-2023.(ifu ref.090200769).Following investigation by depuy warsaw, notification was received that: ¿the returned devices included (1) 129429040 lcs complete rev fem cem l std, (1) 129453126 universal fem slv ful por 31mm, (1) 129424410 lcs comp vvc ins std 10mm and (2) 129427040 lcs com post aug 5mm std.Non-destructive evaluation was conducted by the complaint analyst and material scientist.The devices were submitted with the universal fem slv ful por 31mm disassociated from the lcs complete rev fem cem l std and the two augments attached to the femoral component.There is bone cement covering approximately 95% of the fixation surface with the augments 10% encased in the bone cement.Examination of the universal fem slv ful por 31mm and lcs complete rev fem cem l std tapers surfaces exhibit wear.The sleeve exhibits small regions of corrosion wear at the distal most point of contact between the tapers.The wear on the femoral post is not consistent with corrosion.Due to the wear on the tapers it cannot be determined if the two tapers were initially adequately locked.¿ from the information reviewed it could not be identified whether a potential product issue was present.No corrective action is required and no further investigation is recommended.Post market surveillance is per sep 419.¿ device history lot : null.Device history batch : null.Device history review : null.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: LCS COM POST AUG 5MM STD
• Common Device Name: LCS COMPLETE : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9416109
• Report Number: 1818910-2019-120656
• Device Sequence Number: 18966236
• Product Code: NJL
• UDI-Device Identifier: 10603295025344
• UDI-Public: 10603295025344
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2019

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: 1294-27-040
• Device Catalogue Number: 129427040
• Device Lot Number: 345878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/25/2019; 01/14/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 12/10/2019; 01/22/2020
• 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
• Patient Age: 78 YR
• Patient Weight: 58