MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN BANTAM W/GRIPTION 44MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-30-044
Medical Device Problem Codes	Naturally Worn (2988); Noise, Audible (3273)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/23/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.
Event or Problem Description
Complaint description: patient was revised to address liner disassociation.Update rec'd 10/12/2015 - the patient's medical records were received.Medical records were reviewed for mdr reportability.According to the medical records, the patient was revised to address pain.Upon revision the patient was found to have metallosis in the hip and a damaged liner from impingement.At this time there is no new information that would change the existing mdr decision.The complaint was updated on: 11/09/2015.Update rec'd 8/1/2016- legal claim received.There is no new additional information that would affect the existing mdr decision.Update rec'd 9/1/2016- legal claim received.There is no new additional information that would affect the existing mdr decision.Complaint was updated 09/21/2016.Update apr 19, 2018: litigation records received.Litigation alleges mental and physical pain and squeaking in the hip during post-operative visit.Patient underwent a revision of the acetabular component of the right total hip prosthesis due to mechanical complications.Significant surgical findings included metallosis with dark titanium staining of the joint space, dissociation of the acetabular liner, significant wear of the titanium acetabular shell and damage to the locking mechanism.Cup was reported on the 2nd revsion/complaint.Added head product since this was revised.Updated the date of implant and added new associated contact.Doi: (b)(6) 2015: dor: (b)(6) 2015 (3rd revision).Please see (b)(4) for the 2nd revision.

• Brand Name: PINN BANTAM W/GRIPTION 44MM
• Common Device Name: PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12235125
• Report Number: 1818910-2021-16192
• Device Sequence Number: 3681342
• Product Code: KWA
• UDI-Device Identifier: 10603295009948
• UDI-Public: 10603295009948
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K093646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2015

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 Expiration Date: 06/08/2017
• Device Model Number: 1217-30-044
• Device Catalogue Number: 121730044
• Device Lot Number: BX1F21000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 07/27/2021
• 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
• Patient Age: 47 YR
• Patient Weight: 78