MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 5.0MM DIA TPRD HD PER SCRW 40; BONE SCREWS AND PINS : SCREWS

Model Number	1257-40-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Thrombosis (2100); No Code Available (3191)
Date of Event	05/05/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Clinical adverse event received for pulmonary embolism diagnosed the end of (b)(6).Event is serious and is considered moderate.Event is definitely not related to device and is possibly related to procedure.Date of implantation: (b)(6) 2020.Date of event (onset): (b)(6) 2020.(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.Corrected h6 (2100) used to capture patient code thrombosis was removed since it relates to a different complaint if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
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: b5 and h6 (patient code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Revision operative notes provide information that the primary left tha included an asr cup and head, a ztt femoral sleeve, and an unk depuy femoral stem.Date of implantation and part/lot information were not provided.These products have not been previously reported.Records indicate the primary tha procedure occurred 10 years earlier by a dr.(b)(6) in (b)(6).Dor: (b)(6) 2020: patient received a complete left thr to treat pain and discomfort secondary to armd and massive acetabular and femoral osteolysis.Upon entering the joint, the surgeon identified and excised stained periarticular synovial tissue and fluid consistent with metallosis and foreign body reaction.The pseudocapsule was debrided.There was some deficiency of the gluteus medius, which was repaired.The asr cup was malpositioned and had significant eccentric wear which produced the metallosis.Upon removal of the asr cup, the surgeon identified significant retroacetabular osteolysis which was removed and reconstructed with fresh frozen allograft.The osteolytic lesions in the ischium, pubis, and superior regions of the acetabulum, which required the revision cup to be secured with screws.The ztt femoral sleeve was well in grown but there were osteolytic lesions into the trochanter and around the iliopsoas tendon.The stem was well-fixed but revised due to the femoral osteolysis.Allograft was used to repair the lesions on the femur.The manufacturer of the stem was not identified but assumed to be a depuy product due to the use of the ztt sleeve.The patient received a depuy tha at revision.The procedure was completed without complications.(previously unreported event) phone call dated 05 may 2020: patient called to inform the surgeon about being diagnosed with a pulmonary embolism at the end of april and more recently, with e dvt of an unspecified lower extremity.The patient developed the pe and dvt while on eloquis.The patient reports that the tha is performing nicely.No treatment was identified.The conditions under which the patient developed the pe and dvt were not provided.(captured on (b)(4).Clinic visit dated (b)(6) 2020: patient is four months status post left tha.Physical exam identifies a mild limp due to a 1.09 cm leg length discrepancy.Patient reports some mild soreness that dissipates with walking and no interruption in mobility or adls.X-rays identify a well-fixed, stable tha.No interventions are required, and patient is free to resume full activity as tolerated.(captured on (b)(4).Doi: unknown dor: (b)(6) 2020 doe: (b)(6) 2020 (pe and dvt reported on (b)(4).Doe: (b)(6) 2020 (limb asymmetry reported on (b)(4).Left hip.
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.

• Brand Name: 5.0MM DIA TPRD HD PER SCRW 40
• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10072781
• Report Number: 1818910-2020-12297
• Device Sequence Number: 17087794
• Product Code: LPH
• UDI-Device Identifier: 10603295019893
• UDI-Public: 10603295019893
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K983014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/07/2020

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: 1257-40-000
• Device Catalogue Number: 125740000
• Device Lot Number: J16H97
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 06/04/2020; 06/29/2020; 07/02/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 06/12/2020; 06/29/2020; 07/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM DIA TPRD HD PER SCRW 40; 5.0MM DIA TPRD HD PER SCRW 45; 5.0MM DIA TPRD HD PER SCRW 50; 5.0MM DIA TPRD HD PER SCRW 60; ALTRX +4 10D 36IDX54OD; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX45MM; S-ROM M HEAD 36MM +9
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 86