MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX40MM; BONE SCREWS AND PINS : SCREWS

Model Number	1217-40-500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Muscular Rigidity (1968); Pain (1994); Pocket Erosion (2013); Loss of Range of Motion (2032); Scar Tissue (2060); Synovitis (2094); Distress (2329); Discomfort (2330); Depression (2361); Osteolysis (2377); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	03/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.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 or Problem Description
It was reported that the surgeon requested poly liner for revision of pinnacle metal on metal liner and stem replacement in anticipation of loosening due to increase ion levels.Tissues appeared normal color and stem well fixed from point of view throughout procedure.No surgical delay.Doi: (b)(6) 2009.Dor: (b)(6) 2021.Unknown affected side.
Additional 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.
Event or Problem Description
Medical records were received and stated that the patient was revised on (b)(6) 2023, due to a failed left total hip arthroplasty with metal open metal bearing and metallosis.Surgical notes reported increasing hip pain with evidence of periprosthetic osteolysis.There was a fracture at the junction of the superior pubic ramus and anterior aspect of the acetabulum.The operative noted acetabular component was extracted and two screws remain solidly left in place.
Additional 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.
Additional 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 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.H6 clinical code: unspecified tissue injury (e2015) reported in the previous medwatch was used to capture bone injury and soft tissue injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional 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.
Event or Problem Description
After a review of the medical records, the patient was revised to address metallosis with soft tissue reaction, hip pain, periprosthetic osteolysis, a large fluid collection and fracture of at the junction of the superior pubic ramus and anterior aspect of the acetabulum, local soft tissue reaction with osteolysis.Operative note reported that there was some evidence of deep tissue erosion in the anterior aspect of the gluteus medius, but the bulk of the hip abductor remained firmly attached to the trochanter and reactive synovial tissue was serially excised.Encountered brown fluid this was obtained was taken for culture and gram stain.There was a large amount of clay like brown material under the base of the trunnion similar to that encountered in the surrounding synovial tissues and this was removed.Clinical visit on (b)(6) 2020 reported large left hip joint effusion, previous tear and atrophy of the gluteus minimus, chronic moderate tendinopathy of the proximal left common hamstring tendons without disruption, popping noise, stiffness, weakness, decrease rom, swelling, difficulty with mobility, activity limitation, discomfort and depression.There was some evulsion involving iliopsoas attachment, osteolysis in the acetabular component, affected side: left hip.
Additional 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.H6 clinical symptoms code: swelling/edema (e2338) used to capture swelling and edema and unspecified tissue injury (e2015) used to capture soft tissue injury and bone injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINN CAN BONE SCREW 6.5MMX40MM
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• 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: 16495996
• Report Number: 1818910-2023-05216
• Device Sequence Number: 20485801
• Product Code: LPH
• UDI-Device Identifier: 10603295010395
• UDI-Public: 10603295010395
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K983014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: 1217-40-500
• Device Catalogue Number: 121740500
• Device Lot Number: Z81GN4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 03/23/2023; 04/15/2023; 05/15/2023; 05/22/2023; 10/03/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 03/24/2023; 04/21/2023; 05/15/2023; 06/01/2023; 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2005
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12/14 ARTICUL 40MM M SPEC+1.5.; APEX HOLE ELIM POSITIVE STOP.; PINN CAN BONE SCREW 6.5MMX25MM.; PINN CAN BONE SCREW 6.5MMX40MM.; PINN SECTOR W/GRIPTION 56MM.; PINNACLE MTL INS NEUT40IDX56OD.; TRI-LOCK BPS SZ 3 HI OFFSET.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White