MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 6IN AML SM STATURE 12.0MM; AML IMPLANT : HIP FEMORAL STEM

Model Number	1554-01-121
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Anxiety (2328); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
The patient was revised to address pain.Doi: (b)(6) 2009, dor: (b)(6) 2019; 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.
Event or Problem Description
Litigation reported that the revised product was a depuy asr hip system.Litigation also alleges that the patient has experienced severe pain, weakness, difficulty walking.Fluid retention, anxiety, fear, mental anguish, emotional damages, and elevated blood level of chromium and cobalt.Doi: (b)(6) 2009 and dor: (b)(6) 2019 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 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 (age, dob), a4, a6, b5, b7, d4, g4, h4, h6 (clinical and medical device problem codes).H6 clinical code: - fatigue (e2312) is used to capture weakness and fatigue.- unspecified tissue injury (e2015) is 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.Corrected: a1, d1, d2a, d2b, h6 (impact code).
Event or Problem Description
Pfs alleges pain in femur, weak, fatigue, walking difficulty, stiff bone, limited adl, excessive toxic levels of metal ions in the blood, metallosis in the right hip and tissue.After review of the medical records the patient was revised to address metallosis post mom tha, pain, elevated metal ions, fluid collection on mri.Operative note reported some blood tinged fluid, metallosis, osteolysis, minimal bone loss.Operative notes (b)(6) 2019 indicate the patient received a revision of the right total hip due to increasing metal ion levels, pain, and mri result of fluid collection.Upon entering the joint, slight osteolysis, metallosis and trunnionosis was noted, the joint was debrided.Head, liner, and cup revised.Procedure was completed without indication of complication by the surgeon.Doi: (b)(6) 2009.Dor: (b)(6) 2019.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.Device history lot: he 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: 6IN AML SM STATURE 12.0MM
• Common Device Name: AML IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 11349760
• Report Number: 1818910-2021-03442
• Device Sequence Number: 17004120
• Product Code: LPH
• UDI-Device Identifier: 10603295058236
• UDI-Public: 10603295058236
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K061833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/11/2021

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: 1554-01-121
• Device Catalogue Number: 155401121
• Device Lot Number: DR1EW1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 02/23/2021; 09/06/2022; 10/03/2022
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 02/24/2021; 09/27/2022; 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2009
• 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: APEX HOLE ELIM POSITIVE STOP; ARTICULEZE M HEAD 36MM +1.5; PINNACLE 300 ACET CUP 50MM; PINNACLE MTL INS NEUT36IDX50OD; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Race: White