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

Catalog Number	198725413
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient stated that on (b)(6) 2023 the patient had a complex left knee revision with removal of unknown manufactured products.Depuy components were implanted during this procedure.Since that time, the patient has been experiencing pain, and a sensation of knee locking up/rotating.The patient saw a surgeon who noted that there was a failed junction allowing the femoral stem to rotate.Doi: (b)(6) 2023 , dor: unknown (left knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).E3: the initial reporter has been removed for confidentiality/privacy.The initial reporter is the patient.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
Medical records received: on (b)(6) 2023, the patient had a left revision tka to address left femur osteomyelitis, left tibia osteomyelitis, left knee prosthetic infection, and pain.It was noted that the patient has had multiple infections surgeries and understands that their prognosis for infection free outcome is low.During the procedure the surgeon observed gray, friable appearing synovium(abnormal appearing), depuy components were implanted during this procedure, along with competitor cement and competitor cement restrictor.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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 records evaluation (mre) was not performed.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.
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.

• 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19613290
• Report Number: 1818910-2024-13924
• Device Sequence Number: 6963747
• Product Code: JWH
• UDI-Device Identifier: 10603295079187
• UDI-Public: (01)10603295079187(10)JC7592(17)310930
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 198725413
• Device Lot Number: JC7592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 07/03/2024; 07/03/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/04/2024; 07/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2021
• 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: CEM BONE SURG SIMPLEX: STRYKER; CEM BONE SURG SIMPLEX: STRYKER; CEM BONE SURG SIMPLEX: STRYKER; CEM BONE SURG SIMPLEX: STRYKER; LPS CEMENTED STEM 13X125MM STR; LPS DISTAL FEM COMP XSM LT; LPS SEGMENTAL COMPONENT 35MM; LPS SEGMENTAL COMPONENT 45MM; LPS UNIV TIB HIN INS XSM 12MM; MBT REV TIB TRAY SIZE 3 15MM; MBT TRAY SLEEVE CEM M/L 29MM; P.F.C.* TIB STM EXT 4/5/6 30MM; RESTRICTOR CEM FEM BUCK SZ25MM: SMITH & NEPHEW; SIG TIB CEM STM 13X60 2/2.5/3; SIMPLEX P FULL DOSE PACK: STRYKER; SIMPLEX P FULL DOSE PACK: STRYKER; TRIATHLON ASYM CONE AUGMENT SI: STRYKER LOT: HMA4
• Patient Sex: Male