MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SOL 12.0 STD 8.0 FULL PC 12/14; SOLUTION STEM IMPLANTS : HIP FEMORAL STEM

Model Number	1571-13-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Ambulation or Postural Difficulties (2544)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
An official letter has been received from the health authority with below complaint definition: a patient (name is darkened in attached file) had gone through a hip replacement surgery in (b)(6) 2018 and had no issues until a normal walking gone in (b)(6) 2020 where the patient couldn't take a step.In the radiology imaging performed the next day on (b)(6) 2020, it was seen the implant was broken and it penetrated femur by breaking the bone as well.The patient had another surgery on (b)(6) 2020.The patient also claims that in 2015 and 2018, there were manufacturing defects on the devices and the patients had these implants were re-operated due to implant breakage.
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 : 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: SOL 12.0 STD 8.0 FULL PC 12/14
• Common Device Name: SOLUTION STEM IMPLANTS : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10896441
• Report Number: 1818910-2020-25383
• Device Sequence Number: 11584533
• Product Code: LPH
• UDI-Device Identifier: 10603295060741
• UDI-Public: 10603295060741
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K953703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1571-13-000
• Device Catalogue Number: 157113000
• Device Lot Number: 739040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention