MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KNEE FEMORAL LCS; FEMORAL

Catalog Number UNK KNEE FEMORAL LCS

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)

Patient Problems Ossification (1428); Adhesion(s) (1695); Cyst(s) (1800); Foreign Body Reaction (1868); Unspecified Infection (1930); Muscular Rigidity (1968); Pain (1994); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Article entitled ¿the effect of implant modification the low contact stress experience¿ written by a.Pineda, m.B.Pabbruwe, a.M.Kop, p.Vlaskovsky, and m.Hurworth published in the bone and joint journal science direct in 2019 as reviewed.The aim of this study was to conduct the largest low contact stress (lcs) retrieval study to elucidate the failure mechanisms of the porocoat and duofix femoral component.The latter design was voluntarily recalled by the manufacturer.The study included 104 revised uncemented lcs implants which were analyzed.Patients were either implanted with porocoat implants for duofix implants.Adverse events (based off the aes provided patients experienced more than one adverse event and the data is summarized) reason for removal/observation at removal adverse event(s) possibly associated with unk lcs femoral component 104 device revision and replacements 67 for pain 27 for implant loosening (bone to implant) 29 for joint instability 10 for infection 14 for implant mispositioning 9 for joint stiffness 8 for metallosis 33 for debris tissue staining 26 for bone reabsorption 53 for scar tissue 3 for heterotopic ossification 8 for effusion/cyst adverse event(s) possibly associated with unk lcs tibial component 104 device revision and replacements 67 for pain 27 for implant loosening (bone to implant) 29 for joint instability 10 for infection 14 for implant mispositioning 9 for joint stiffness 8 for metallosis 33 for debris tissue staining 26 for bone reabsorption 53 for scar tissue 3 for heterotopic ossification 8 for effusion/cyst adverse event(s) possibly associated with unk lcs tibial insert 104 device revision and replacements 67 for pain 29 for joint instability 10 for infection 9 for joint stiffness 8 for metallosis 23 for osteolysis 33 for debris tissue staining 26 for bone reabsorption 53 for scar tissue 3 for heterotopic ossification 8 for effusion/cyst.

Manufacturer Narrative

Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.The size of the article is too large to attach/submit with the 3500a submission.The citation of the article has been provided below: ¿the effect of implant modification the low contact stress experience¿ written by a.Pineda, m.B.Pabbruwe, a.M.Kop, p.Vlaskovsky, and m.Hurworth published in the bone and joint journal science direct in 2019 as reviewed.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.

Manufacturer Narrative

Product complaint#: (b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the 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.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: UNK KNEE FEMORAL LCS
• Type of Device: FEMORAL
• 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: 19132379
• MDR Text Key: 340450293
• Report Number: 1818910-2024-08557
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK KNEE FEMORAL LCS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/23/2024
• 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