MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE MTL INS NEUT36IDX50OD; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS

Catalog Number 121887350

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Osteolysis (2377); Test Result (2695); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/21/2018

Event Type  Injury  

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 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 asymmetric 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.

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.The reported device code dislodged or dislocated is being retracted as per additional information received.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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.

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 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 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.

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: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.

• Brand Name: PINNACLE MTL INS NEUT36IDX50OD
• Type of Device: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10471044
• MDR Text Key: 204893847
• Report Number: 1818910-2020-19038
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121887350
• Device Lot Number: 2539889
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE SECTOR II CUP 50MM; SUMMIT POR TAPER SZ3 HI OFF; ARTICULEZE M HEAD 36MM +5; PINN CAN BONE SCREW 6.5MM X 20MM; PINN CAN BONE SCREW 6.5MM X 25MM; PINNACLE SECTOR II CUP 50MM; SUMMIT POR TAPER SZ3 HI OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 66 KG