MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA FEM ADAPTER NEUTRAL BOLT; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Model Number 96-0783

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Itching Sensation (1943); Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Information and medical records) reviewed, which indicated: on (b)(6) 2017, patient received primary left total knee replacement (using stemmed depuy tc3 and mbt revision components to address knee instability and pain, secondary to post-traumatic gonarthrosis.She had no intraoperative complications.Following surgery, she developed ongoing pain, swelling, and redness, with concern that she might either be experiencing infection or a hypersensitivity reaction.Ct scan displayed increased uptake around the knee suggesting inflammatory response.Standard allergy testing for food and environmental allergens proved negative, but she tested positive for metal sensitivity to nickel, with slight reaction to cobalt as well.A first stage of a two stage revision was performed with complete explantation of all implants, on (b)(6) 2020.Cultures were submitted to identify possible infection.An antibiotic spacer was placed for treatment in the interim period.Cultures taken produced no evidence of bacteria.She experienced erythematosus (redness of the skin) and transient itching, and her infection parameters in her blood remained elevated during the period between stage one and two revisions.A second test, to also rule-out bone cement, confirmed the nickel allergy, but showed no evidence of cobalt or bone cement sensitivity.The second stage took place on (b)(6) 2020.Competitor non-nickel containing definitive implants were re-implanted with the completion of treatment.

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: SIGMA FEM ADAPTER NEUTRAL BOLT
• Type of Device: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12025726
• MDR Text Key: 263476018
• Report Number: 1818910-2021-13007
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295233930
• UDI-Public: 10603295233930
• Combination Product (y/n): N
• PMA/PMN Number: K060515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 96-0783
• Device Catalogue Number: 960783
• Device Lot Number: H61385
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MBT REVISION CEM TIB TRAY SZ 3.; PALACOS CEMENT:85654583,85444557.; PFC*SIGMA TC3 FEM LEFT SZ3.; SIGMA FEM ADAPTER 5 DEGREE.; SIGMA FEM ADAPTER NEUTRAL BOLT.; TC3 RP TIBIAL INSERT S3,12.5.; UNIVERSAL STEM 75X16MM FLUTED.; UNIVERSAL STEM 75X16MM FLUTED.; UNKNOWN KNEE PATELLA.
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR