MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS SEGMENTAL COMPONENT 85MM; LPS AND S-ROM : KNEE ACCESSORY

Model Number	1987-07-085
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	10/23/2021
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
It was reported that the patient presents with pain in femur and x-rays show what appears to be a loose femoral sleeve.Patient is taken to or to revise femoral implant with suspicion of infection due to his repeated infection history.Frozen section showed 7 white cells per hpf.Surgeon chose to remove all components and replace the knee in a one stage revision utilizing a dual stage set up.Antibiotic beads were placed in addition to coating the non articulating portion of the component with high does antibiotic cement.Doi: (b)(6) 2020, dor: (b)(6) 2021, left knee.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: device x-rays associated with this report were received for examination and found no evidence of device issue.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 SEGMENTAL COMPONENT 85MM
• Common Device Name: LPS AND S-ROM : KNEE ACCESSORY
• 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: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12779145
• Report Number: 1818910-2021-24640
• Device Sequence Number: 17070768
• Product Code: JWH
• UDI-Device Identifier: 10603295078579
• UDI-Public: 10603295078579
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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: 1987-07-085
• Device Catalogue Number: 198707085
• Device Lot Number: J8269G
• 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: 10/23/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2020
• 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: ATTUNE REV LPS INSRT XXSM 12MM.; ATUN TIB SLV M/L 37MM HALF POR.; ATUNE PRESSFIT STR STEM18X60MM.; ATUNE REV RP TIB BASE SZ 4 CEM.; CONTROL CABLE W/CABLE SLEEVE.; LPS DISTAL FEM COMP XXSM LT.; LPS FEM TO SLEEVE ADAPTER +5.; LPS SEGMENTAL COMPONENT 85MM.; UNIVERSAL FEM SLV FUL POR 31MM.; UNIVERSAL STEM 75X16MM FLUTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 65 KG