MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US AML SM STATURE 15.0MM; AML IMPLANT : HIP FEMORAL STEM

Model Number	1554-01-150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Adhesion(s) (1695); Calcium Deposits/Calcification (1758); Fall (1848); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Pain (1994); Weakness (2145); Injury (2348); Ambulation or Postural Difficulties (2544); No Code Available (3191)
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
After review of medical records it was indicated that on post revision, the patient experienced hyponatremia with a sodium level of 133 mmol/l and blood loss anemia with a hemoglobin of 8.4 gm/dl and hematocrit of 25.3%.The patient was administered 2 units of packed red blood cells.Hyponatremia was treated with a restriction of free water intake of 1800cc/day and encouraged intake of electrolyte water and soups.Electrolytes were to be re-checked in 1-2 weeks at rehab.Doi: (b)(6) 2005 (cup).Doi: (b)(6) 2018 (head, liner, stem).Dor: none reported.Right 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 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: b7.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
After review of medical records, visit notes on (b)(6) 2018 reported that the patient complaints of right hip, thigh, and groin pain.After review of medical records, the patient had performed multiple surgeries on the right hip.On (b)(6) 2019, the patient had a rotational event to her femur and it broke and she fell.Then was revised for periprosthetic femur fracture, right, previous right hip replacement with significant trochanteric bursitis, contracture of right hip and complete wound right hip.Operative notes reported that patient had a large amount of fluid and a large trochanteric bursa.There was an implantation of large locking plate and screws.No implants removed.On (b)(6) 2019, the patient undergone revision femoral stem with proximal femoral replacement.Operative procedure performed, biopsy and frozen section right hip; removal right femoral plate; proximal femoral resection; revision femoral stem with proximal femoral replacement; resection heterotropic ossification; and abductor imbrication right hip.On (b)(6) 2019, the patient complained for dislocation, then was revised for right hip open reduction acetabular liner revision; scar excision and closure.It was also indicated that patient was positive on leg length discrepancy.Doi: doi: (b)(6) 2005 (cup).Doi: (b)(6) 2018 (head, liner, stem).Dor: (b)(6) 2019 (stem, head).Dor: (b)(6) 2019 (liner).Right 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.H10 additional narrative: h6 patient code: no code available (3191) was used to capture device revision or replacement, bursitis, and limb asymmetry.
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.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.
Event or Problem Description
Additional information received stated that the patient was last seen on (b)(6) 2019 and stated that hands and legs buckle when walking.By buckle means legs are weak.Weakness of both lower extremities, gait abnormality, and weight loss.
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.H10 additional narrative: 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 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: a5 (ethnicity,race) and b7.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.

• Brand Name: AML SM STATURE 15.0MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10135712
• Report Number: 1818910-2020-13527
• Device Sequence Number: 19561070
• Product Code: JDI
• UDI-Device Identifier: 10603295058250
• UDI-Public: 10603295058250
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/27/2020

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: 1554-01-150
• Device Catalogue Number: 155401150
• Device Lot Number: HN3752
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 07/15/2020; 07/22/2020; 09/10/2020; 09/16/2020; 10/16/2020; 10/21/2020; 12/10/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 07/16/2020; 07/27/2020; 09/21/2020; 10/01/2020; 10/28/2020; 11/03/2020; 12/10/2020
• 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: ALTRX NEUT 36IDX52OD.; DELTA CER HEAD 12/14 36MM +1.5.; UNKNOWN HIP ACETABULAR CUP.; ALTRX NEUT 36IDX52OD; DELTA CER HEAD 12/14 36MM +1.5; UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR