MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS CEMENTED STEM 11X100MM STR; LPS AND S-ROM : KNEE STEMS

Model Number	1987-25-111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060)
Date of Event	08/31/2021
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 for patella scarring/ clunking and pain - appeared to be tissue rubbing on porous collar on lps stem.Lps removed and lps with sleeve put in.Doi: unknown.Dor: (b)(6) 2021, unknown side.
Additional Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination an australian hospital described the complaint as: revision lps for patella scarring/clunking and pain - appeared to be tissue rubbing on porous collar on lps stem; lps removed and lps with sleeve put in.All available photographs were reviewed and there is no evidence to confirm this complaint.Visual inspection of the pictures does not confirm the complaint.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 11X100MM 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: 12513044
• Report Number: 1818910-2021-20768
• Device Sequence Number: 14461065
• Product Code: LPH
• UDI-Device Identifier: 10603295079156
• UDI-Public: 10603295079156
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 09/01/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1987-25-111
• Device Catalogue Number: 198725111
• Device Lot Number: J4646R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/08/2021
• 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: LPS DISTAL FEM COMP XSM LT; LPS UNIV TIB HIN INS XSM 16MM; LPS XX-SM HINGE PIN; MBT REVISION CEM TIB TRAY S2.5; MBT TRAY SLEEVE POR M/L 53MM; PFC*SIGMA/OV/DOME PAT 3PEG,38; UNIVERSAL STEM 75X12MM FLUTED
• Outcome Attributed to Adverse Event: Required Intervention