MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS CEMENTED STEM 13X125MM STR; LPS AND S-ROM : KNEE STEMS

Model Number	1987-25-413
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Revision lps distal femur - loosening at femoral implant interface.Cemented stem lps insitu - wide canal on male patient thought to be the reason for loosening at interface.Doi: unknown, dor: unknown, unknown side.
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 no device associated with this report was received for examination.All available x-rays were reviewed, and no evidence of implant fracture, disassociation, or anything indicative of a device nonconformance was found.The lps cemented stem 13x125mm str in the photograph looks devoid of cement, bone or debris of any kind on the surface, but no indicative proof of loosening.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.

• Brand Name: LPS CEMENTED STEM 13X125MM STR
• Common Device Name: LPS AND S-ROM : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12460307
• Report Number: 1818910-2021-19932
• Device Sequence Number: 1194735
• Product Code: JWH
• UDI-Device Identifier: 10603295079187
• UDI-Public: 10603295079187
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2021

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
• Operator of Device: No Information
• Device Model Number: 1987-25-413
• Device Catalogue Number: 198725413
• Device Lot Number: C78269
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 09/13/2021; 10/18/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 09/27/2021; 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMPETITOR CEMENT; LPS CEMENTED STEM 13X125MM STR; LPS DISTAL FEM COMP XSM RT; LPS UNIV TIB HIN INS XSM 18MM; LPS XX-SM HINGE PIN; LPS CEMENTED STEM 13X125MM STR; LPS DISTAL FEM COMP XSM RT; LPS UNIV TIB HIN INS XSM 18MM; LPS XX-SM HINGE PIN
• Outcome Attributed to Adverse Event: Required Intervention