MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT DUOFIX TAP SZ4 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-02-100

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

Patient Problems Fatigue (1849); Inflammation (1932); Pain (1994); Numbness (2415)

Event Date 12/08/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).E3 initial reporter occupation: lawyer.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical records received.On (b)(6) 2022, the patient reports having back pain, right hip pain, and right leg pain.On (b)(6) 2023, the patient reports having pain in lower back, with radiation to the right groin.There is associated chronic right leg weakness continue to worsen and bilateral feet numbness and tingling.Patient has completed extensive physical therapy.Doi: (b)(6) 2009 (cup and stem); doi: (b)(6) 2022 (head and liner); doe: (b)(6) 2022; right hip.

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 : 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 DUOFIX TAP SZ4 STD OFF
• Type of Device: 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16888040
• MDR Text Key: 314758930
• Report Number: 1818910-2023-09848
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295059455
• UDI-Public: 10603295059455
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

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 Expiration Date: 01/31/2018
• Device Model Number: 1570-02-100
• Device Catalogue Number: 157002100
• Device Lot Number: CD5KV1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 06/02/2023
• Supplement Dates FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2008
• 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: DLT TS CER HD 12/14 28MM +5.0; PINN LNR CON +4 NEUT 28IDX50OD; PINNACLE 100 ACET CUP 50MM; SUMMIT DUOFIX TAP SZ4 STD OFF
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female