MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ3 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number	1570-11-090
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Foreign Body Reaction (1868); Bone Fracture(s) (1870); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Test Result (2695); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/21/2018
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
Pinnacle medical records received.After review of the medical records the patient was revised to address periprosthetic fracture, osteolysis and significant adverse local tissue reaction related to mom and metallosis resulting to pain in her right hip.Operative note reported gray fluid and was sent for culture.There was soft tissue reaction with significant metallosis and proximal osteolysis in the femur.There was also significant asymetric anterior wear of the liner with deformation of the metal liner.Mri showed significant adverse local tissue reaction and metal ions reported above 7 ppb.Doi: (b)(6) 2008.Dor: (b)(6) 2018; 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.
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: a4 (patient).H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the bone injury.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
Ppf alleges bone fracture, metal wear, metallosis, abductor muscle repair and elevated metal ions.Pfs alleges loss of muscle and bone, limited range of motion and pain due to metal damage.After review of the medical records there was no new patient harm and device deficiency provided all were capture in the previous medical records.However, after the first revision patient had dislocation and instability that leads to the second revision.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: update 02 may 2022: 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.

• Brand Name: SUMMIT POR TAPER SZ3 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• 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: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10471043
• Report Number: 1818910-2020-19036
• Device Sequence Number: 19369933
• Product Code: JDI
• UDI-Device Identifier: 10603295060048
• UDI-Public: 10603295060048
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/13/2020

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: 1570-11-090
• Device Catalogue Number: 157011090
• Device Lot Number: X4RCY1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 10/08/2020; 04/21/2022; 05/02/2022
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 10/08/2020; 05/03/2022; 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2003
• 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: ARTICULEZE M HEAD 36MM +5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT36IDX50OD; PINNACLE SECTOR II CUP 50MM; ARTICULEZE M HEAD 36MM +5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE MTL INS NEUT36IDX50OD; PINNACLE SECTOR II CUP 50MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 66 KG