MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM RT SZ 4; KNEE FEMORAL

Model Number 96-0014

Device Problem Noise, Audible (3273)

Patient Problems Erythema (1840); Fatigue (1849); Hemorrhage/Bleeding (1888); Inflammation (1932); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6) 2022 1:35pm: spoke with patient via phone.Patient indicated he was implanted with a right depuy knee (cement mfg unknown) in (b)(6) 2020.He subsequently underwent a manipulation under anesthesia in (b)(6) 2021 for continued pain.Post manipulation the patient reports he continues to have pain (complex pain syndrome diagnosed prior to knee placement in 2020), weakness, sciatic nerve pain, spasms, redness, decreased rom, cracking, swelling, clicking.Mris and x-rays show the debonding of the cement at the cement to tibial tray interface.Patient indicates he is currently taking pain medications, but hasn't undergone any additional surgical intervention since the manipulation in (b)(6) of 2021.Patient is calling to determine if his implants are involved within any recalls.At this time the patient doesn't have access to the part/lot information, but has agreed to sign authorization forms.Patient was informed that once depuy synthes receives the signed authorization forms, the forms will be sent to the medical providers to request his medical records.Once medical records are received, part/lot information will be reviewed to determine if any implants are involved within a recall.Patient would prefer the authorization forms were mailed to him at the address on record.Patient has no other questions/concerns at this time and was provided call back information if any additional questions arrive.Patient was informed he will receive a phone call once we received his signed authorization forms back.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the patient that he is currently in the website for a depuy knee recall and he is hoping if someone he can speak with.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Event Description

Medical records reviewed: (b)(6) 2018, partial replacement (no further info provided).(b)(6) 2019 revision, manipulation (no further info provided).On (b)(6) 2020, arthroplasty knee total revision right to address pain and limited range of motion.Patient was noted, to have chronic synovitis.The surgeon did an extensive synovectomy and removal of the femoral prosthesis.The patella was not revised.Depuy implants were used, during this procedure, along with competitor cement x2.

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.

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.H10 additional narrative: added: d4 (lot, catalog, udi), g4 (pma/ 510(k)), h4 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2a, d10 (concomitant med products).

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 manufacturing 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.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary; no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot; a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

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.H10 additional narrative: added: h6 health effect - clinical code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Type of Device: KNEE FEMORAL
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14743934
• MDR Text Key: 294953825
• Report Number: 1818910-2022-11284
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295232032
• UDI-Public: 10603295232032
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96-0014
• Device Catalogue Number: 960014
• Device Lot Number: D20032642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2020
• 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
• Treatment: PALACOS CEMENT (COMPETITOR, UNK MANUFACTURER).; SIG MOD TIB TRAY CEM COCR 3.; SIGMA XLK CVD PLUS INS 3 10MM.; UNK KNEE TIBIAL INSERT.; UNKNOWN KNEE FEMORAL.; UNKNOWN KNEE TIBIAL TRAY.
• Patient Outcome(s): Required Intervention