MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM NRHFEM W/PIN XSMLFT 66X58; LPS AND S-ROM : KNEE FEMORAL

Model Number	62-3421L
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	10/05/2020
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
These were revised due to the patient complaining of pain which was determined to be caused by the stem tip being in contact with the cortical bone.The original surgery was completed in (b)(6) 2020.The explants are not available for review.If x-rays are required they may not be available as the patients permission will be required.The surgeon does not require any follow-up.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: SROM NRHFEM W/PIN XSMLFT 66X58
• Common Device Name: LPS AND S-ROM : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10733086
• Report Number: 1818910-2020-23271
• Device Sequence Number: 11599508
• Product Code: JWH
• UDI-Device Identifier: 10603295179504
• UDI-Public: 10603295179504
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K905810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• 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): 10/06/2020

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: 62-3421L
• Device Catalogue Number: 623421L
• Device Lot Number: J1071T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 12/11/2020
• 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 UNIV TIB HIN INS XSM 12MM; SIGTIBCEMSTM 13X30 1.5/2/2.5/3; SROM NRH DIST AUG XS/S/MD 5MM; SROM NRH DIST AUG XS/S/MD 5MM; UNIVERSAL FEM SLV FUL POR 34MM; LPS UNIV TIB HIN INS XSM 12MM; SIGTIBCEMSTM 13X30 1.5/2/2.5/3; SROM NRH DIST AUG XS/S/MD 5MM; SROM NRH DIST AUG XS/S/MD 5MM; UNIVERSAL FEM SLV FUL POR 34MM
• Outcome Attributed to Adverse Event: Required Intervention