MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNIVERSAL STEM 75X20MM FLUTED; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-7419
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Doi (b)(6) 2014: the infection was cleared and an lps distal femur, segment component, sleeve adaptor, femoral sleeve, lps tibial hinge insert, universal stem, mbt tray, mbt sleeve, and universal stem (see additional information provided with part/lot) was implanted.A free latissimus dorsi flap with vein grafting to correct a left knee skin defect present before the revision was also performed.Postoperatively, the developed acute renal failure requiring increasing iv fluids.This was captured in (b)(4).On (b)(6) 2014: the latissimus dorsi flap is positive for pseudomonas and stenotrophomonas maltophilia requiring iv antibiotics and a wound vac dressing to address the drainage.The infection is cleared though the patient is told to remain on chronic antibiotics.This was captured in (b)(4).On (b)(6) 2014: the extensor mechanism has ¿slid proximally¿ causing bone graft to come loose and patella to ride high per radiographs in reference to his allograft reconstruction with residual rom and strength deficits.No surgical intervention is to be done.He is to continue physical therapy only.This was captured in (b)(4).Early (b)(6) 2014: the patient sustains a fall due to a sense of instability in the knee.No intervention is done.This was captured in (b)(4).On (b)(6) 2015: patient complains of pain and swelling.On (b)(6) 2015: i&d of left knee is performed due to elevated esr and crp values.Cultures are positive for stephylococcus intermedius.The patient is treated with iv cloxacillin.Doi: (b)(6) 2014.Doe: (b)(6) 2015.Affected knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).The devices are reported under (b)(4).As the patient experienced adverse events on different days with the same devices.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).The devices are reported under (b)(4).As the patient experienced adverse events on different days with the same devices.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
Doi (b)(6) 2014: the infection was cleared and an lps distal femur, segment component, sleeve adaptor, femoral sleeve, lps tibial hinge insert, universal stem, mbt tray, mbt sleeve, and universal stem (see additional information provided with part/lot) was implanted.A free latissimus dorsi flap with vein grafting to correct a left knee skin defect present before the revision was also performed.Postoperatively, the developed acute renal failure requiring increasing iv fluids.This was captured in (b)(4).On (b)(6) 2014: the latissimus dorsi flap is positive for pseudomonas and stenotrophomonas maltophilia requiring iv antibiotics and a wound vac dressing to address the drainage.The infection is cleared though the patient is told to remain on chronic antibiotics.This was captured in (b)(4).On (b)(6) 2014: the extensor mechanism has ¿slid proximally¿ causing bone graft to come loose and patella to ride high per radiographs in reference to his allograft reconstruction with residual rom and strength deficits.No surgical intervention is to be done.He is to continue physical therapy only.This was captured in (b)(4).Early (b)(6) 2014: the patient sustains a fall due to a sense of instability in the knee.No intervention is done.This was captured in (b)(4).On (b)(6) 2015: patient complains of pain and swelling.On (b)(6) 2015: i&d of left knee is performed due to elevated esr and crp values.Cultures are positive for stephylococcus intermedius.The patient is treated with iv cloxacillin.Doi: (b)(6) 2014.Doe: (b)(6) 2015.Affected knee.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.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.However, if the product is received at a later date, the investigation will be updated as applicable.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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: UNIVERSAL STEM 75X20MM FLUTED
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13584011
• Report Number: 1818910-2022-03328
• Device Sequence Number: 17235470
• Product Code: JWH
• UDI-Device Identifier: 10603295217855
• UDI-Public: 10603295217855
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2022

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: 86-7419
• Device Catalogue Number: 867419
• Device Lot Number: 443282
• 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: 02/07/2022
• Supplement Date Received by Manufacturer: 03/26/2022; 04/13/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/28/2022; 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2013
• 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: ALLOSOURCE TISSUE (104682109/189117002).; LPS DISTAL FEM COMP XXSM LT.; LPS FEM TO SLEEVE ADAPTER +5.; LPS SEGMENTAL COMPONENT 45MM.; LPS UNIV TIB HIN INS XXSM 18MM.; MBT REV TIB TRAY SIZE 2 25MM.; MBT TRAY SLEEVE POR M/L 61MM.; STRYKER CEMENT (61969001).; STRYKER CEMENT (61971001).; STRYKER CEMENT (61971001).; STRYKER CEMENT (61971001).; STRYKER CEMENT (61971001).; STRYKER CEMENT (61971001).; UNIVERSAL FEM SLV FUL POR 34MM.; UNIVERSAL STEM 75X16MM FLUTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Unknown
• Patient Weight: 123 KG