MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS CEM FEM STEM 13X200MM BOW; LPS AND S-ROM : KNEE STEMS

Model Number	1987-15-313
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	11/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent lps distal femoral replacement on (b)(6) 2014.Patient then presented with a loose distal femoral replacement which was revised to another distal femoral replacement with cemented stem on (b)(6) 2015 ((b)(6) hospital).(a pc would have been submitted).Patient has again presented with a loose distal femoral replacement along with proximal femoral fractures.A decision was made to remove the distal femoral replacement, leave the existing mbt revision tray in situ and replace the distal femoral replacement with a total femoral replacement - do to lack of proximal bone and the view that cementing in another distal femur would result in further loosening.((b)(6) hospital, (b)(6) 2022).
Additional Manufacturer Narrative
Product complaint #: (b)(4).The device catalog number is unknown; therefore, udi # is unavailable.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary; the device was not returned to depuy synthes for evaluation, however x-ray were provided for review.Review of the provided x-ray reveled that is not possible determinate damage or defects.The report allegation cannot be confirmed.There is not enough evidence in the photo to confirm the allegation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot; the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative: added: d10.

• Brand Name: LPS CEM FEM STEM 13X200MM BOW
• Common Device Name: LPS AND S-ROM : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15852428
• Report Number: 1818910-2022-23619
• Device Sequence Number: 12041407
• Product Code: JWH
• UDI-Device Identifier: 10603295078814
• UDI-Public: 10603295078814
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K003182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/23/2022

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: 1987-15-313
• Device Catalogue Number: 198715313
• Device Lot Number: EH2NL1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 11/23/2022; 01/25/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 12/05/2022; 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; LPS CEM FEM STEM 13X200MM BOW; LPS DISTAL FEM COMP XSM RT; LPS DISTAL FEM COMP XSM RT; LPS SEGMENTAL COMPONENT 35MM; LPS SEGMENTAL COMPONENT 35MM; LPS SEGMENTAL COMPONENT 45MM; LPS SEGMENTAL COMPONENT 45MM; LPS UNIV TIB HIN INS XSM 12MM; LPS UNIV TIB HIN INS XSM 12MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male