MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SOL 21.0 BOW LT 8.0 12/14; SOLUTION STEM IMPLANTS : HIP FEMORAL STEM

Model Number 1571-79-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Discomfort (2330); Injury (2348); Test Result (2695); No Code Available (3191)

Event Date 01/05/2018

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 claim submission form and medical records received.After review of the medical records the patient was revised due to pain, discomfort with elevated metal ions.Operative note reported abundant amount of capsular tissue was excised and some inferior bone.However, there were no lab result provided for the metal ions.Doi: (b)(6) 2006.Dor: (b)(6) 2018; left hip 2nd revision.

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: SOL 21.0 BOW LT 8.0 12/14
• Type of Device: SOLUTION STEM IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10574031
• MDR Text Key: 208144777
• Report Number: 1818910-2020-20728
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295061236
• UDI-Public: 10603295061236
• Combination Product (y/n): N
• PMA/PMN Number: K953703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

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
• Device Operator: Health Professional
• Device Model Number: 1571-79-000
• Device Catalogue Number: 157179000
• Device Lot Number: US4JE1001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5.0MM DIA TPRD HD PER SCRW 55; 5.0MM DIA TPRD HD PER SCRW 55; ARTICULEZE M HEAD 36MM +8.5; CONTROL CABLE W/CABLE SLEEVE; CONTROL CABLE W/CABLE SLEEVE; CONTROL CABLE W/CABLE SLEEVE; CONTROL CABLE W/CABLE SLEEVE; PINNACLE DP REV ACET CUP 62MM; PINNACLE MTL INS NEUT36IDX56OD; 5.0MM DIA TPRD HD PER SCRW 55; 5.0MM DIA TPRD HD PER SCRW 55; ARTICULEZE M HEAD 36MM +8.5; CONTROL CABLE W/CABLE SLEEVE; CONTROL CABLE W/CABLE SLEEVE; CONTROL CABLE W/CABLE SLEEVE; CONTROL CABLE W/CABLE SLEEVE; PINNACLE DP REV ACET CUP 62MM; PINNACLE MTL INS NEUT36ID X 56OD
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 120