MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE PATELLA SIGMA

Catalog Number UNK KNEE PATELLA

Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Muscular Rigidity (1968); Nerve Damage (1979); Pain (1994); Impaired Healing (2378); Joint Laxity (4526); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The published article ¿comparison of existing and new total knee arthroplasty implant systems from the same manufacturer: a prospective, multicenter study¿ by william g.Hamilton, md, ivan j.Brenkel, frcs, steven l.Barnett, md, paul w.Allen, frcs, kimberly a.Dwyer, phd, ccra, james p.Lesko, phd, stephen r.Kantor, md, mark g.Clatworthy, mbchb, fracs published on december 2021 in the american academy of orthopaedic surgeons was reviewed for adverse events.The purpose of the article was to compare the outcomes over two years of 752 pfc sigma knee constructs to 1129 attune knee constructs.Cement manufacturer is unknown.The study included cohorts from the united states, united kingdom, australia, and new zealand.The following adverse events were identified.Pfc sigma underwent 11 revisions for the following reason: infection, instability, loosening, pain.Attune underwent 20 revisions for the following reason: bone fracture,crepitus, infection, loosening, pain, stiffness.The following adverse events were noted with no information regarding the intervention required.Pfc sigma: stiffness (75), pain (21), infection (18), effusion (11), crepitus-asymptomatic (15), instability (12), crepitus-symptomatic (15), trauma (5), wound complication (8), bone fracture (4), tendinitis (6), neuralgia (2), and loosening (3).Attune: stiffness (85), pain (56), infection (27), effusion (30), crepitus-asymptomatic (13), instability (14), crepitus-symptomatic (6), trauma (15), wound complication (7), bone fracture (13), tendinitis (6), neuralgia (8), and loosening (1).Radiographic outcomes included the following: pfc sigma: implant/cement interface gap immediately post-op: femoral (6) and tibial (9).Attune: implant/cement interface gap immediately post-op: femoral 928) and tibial (15).Radiolucencies were also identified: pfc sigma: femoral (3) and tibial (1).Attune: femoral (3) and tibial (1).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK KNEE PATELLA SIGMA
• Type of Device: KNEE PATELLA
• 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
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16825582
• MDR Text Key: 314115770
• Report Number: 1818910-2023-08910
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE PATELLA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 04/27/2023
• Supplement Dates Manufacturer Received: 06/05/2023
• Supplement Dates FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention