MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN SECTOR W/GRIPTION 48MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 121732048

Device Problems Device Dislodged or Dislocated (2923); Noise, Audible (3273)

Patient Problems Adhesion(s) (1695); Pain (1994); Discomfort (2330)

Event Date 12/06/2021

Event Type  Injury  

Event Description

Litigations received.On date (b)(6) 2020 patient received a right hip joint implant.Patient began having difficulties with her right hip and complained that it started to squeak loudly.Patient must require to have a revision due to implant was broken from mri results.On (b)(6) 2022, another right hip revision was performed due to failed polyethylene liner.The failure of the original implant caused injury, harm, pain, and scars.The failure of the implant, as noted by the physicians, was that the liner of the depuy pinnacle cup had dislodged in patient's hip area.The patients information and belief, defendants recalled the items which was implanted in her hip, pinnacle cup.This was seen with a recall date of dec.15, 2020, after the date the hip implant was place in patient's body on (b)(6) 2020.Implant was recalled due to oversized "minor diameter" that can cause the apex he to thread through the shell of the cup without stopping or to protrude internally as a result of cross threading.Doi: (b)(6) 2020.Dor: (b)(6) 2021.Right hip.

Manufacturer Narrative

Product complaint # (b)(4).E3 initial reporter occupation: lawyer.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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 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.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).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: a2, a3, b3, b7, d4 (lot, expiration), d10, h4.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A1.

Event Description

Medical records were received: on (b)(6) 2020 the patient had a right total hip arthroplasty to address end stage degenerative joint disease.*on (b)(6) 2021, the patient had a left total hip arthroplasty with ceramic on polyethylene to address severe degenerative joint disease.Depuy components were implanted during this procedure.*on (b)(6) 2021, the patient had a revision right total hip arthroplasty to address failed polyethylene liner right total hip arthroplasty.Prior to surgery, the patient was noted to have experienced pain/discomfort and loud squeaking in the right hip.Preop radiographs were reported to show metal on metal contact with the femoral head and acetabular component suggesting failure of polyethylene liner.

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).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 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.Update 4/25/2024 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 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).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.

Event Description

Medical records received.10/22/2015 radiograph reports state: trauma, findings include that the fractures of the bilateral superior and inferior pubic rami demonstrates early none bridging callus formation.The comminuted fracture of the right pubis body demonstrates continued healing changes.(prior to depuy products).(b)(6) 2020 right hip arthroplasty (no part/lot).(b)(6) 2021 left hip arthroplasty (no part/lot).(b)(6) 2021 right hip arthroplasty (no part/lot).On 11/17/2022 medical records note ap pelvis shows what appears to be a stable right total hip arthroplasty with no acute fracture.Stable left total arthroplasty was well.The patient reports right hip pain.(captured in (b)(4).).

• Brand Name: PINN SECTOR W/GRIPTION 48MM
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• 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: 17879216
• MDR Text Key: 325021205
• Report Number: 1818910-2023-20330
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: 10603295010289
• UDI-Public: 10603295010289
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/05/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121732048
• Device Lot Number: 9515746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 04/16/2024; 04/16/2024; 04/25/2024
• Supplement Dates FDA Received: 04/22/2024; 04/24/2024; 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2020
• 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: ALTRX +4 10D 32IDX48OD; DELTA CER HEAD 12/14 32MM +5; PINN CAN BONE SCREW 6.5MMX35MM; PINN SECTOR W/GRIPTION 48MM; SUMMIT POR TAPER SZ4 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female