MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MULTIHOLE W/GRIPTION 58MM; PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS

Model Number	1217-30-058
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	04/14/2015
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.Occupation: attorney.
Event or Problem Description
Complaint description: litigation alleges patient suffers from pain, difficulty walking, and feeling that his right hip is not in the correct place.Update 7/8/2015-pfs and medical records received.After review of the medical records for mdr reportability, the part/lot is being updated.It should be noted that the doi of (b)(6) 2009 is a revision operation from a previous hip replacement.Manufacturer of the products involved are unknown at this time.The complaint was updated on: 7/8/2015.Update ad 30 oct 2018: ppf alleges dislocation and loosening of cup.Added dor, age, law firm, lawyer, hospital, surgeon, patient harm, new ip's and pec.Doi: (b)(6) 2009.Dor: (b)(6) 2010.(right hip).
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.

• Brand Name: PINN MULTIHOLE W/GRIPTION 58MM
• 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: 9226854
• Report Number: 1818910-2019-111563
• Device Sequence Number: 11165579
• Product Code: LPH
• UDI-Device Identifier: 10603295010012
• UDI-Public: 10603295010012
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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
• Operator of Device: Health Professional
• Device Model Number: 1217-30-058
• Device Catalogue Number: 121730058
• Device Lot Number: CV7GM1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 09/15/2020
• 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: 60 YR
• Patient Weight: 69