MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 28IDX58OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Model Number	1219-28-058
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/18/2020
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
Notified that surgeon performed a pinnacle liner dissociation revision case at (b)(6).Surgeon reported that the liner had likely dissociated due to poor implantation technique and noted soft tissue underneath the ard tab of the liner.The revision liner proceeded as planned with no adverse patient outcome.Primary thr performed by (b)(6)2016.No further information available.
Event or Problem Description
Additional information indicated that the affected side is the right.
Additional Manufacturer Narrative
Product complaint # (b)(4).No device associated with this report was received for examination.Examination of the provided x-ray and photograph images finds sufficient evidence to confirm the reported disassociation event.It was not possible to determine a root cause.There is nothing noted to indicate a product problem.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

• Brand Name: PINN MAR NEUT 28IDX58OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10619610
• Report Number: 1818910-2020-21448
• Device Sequence Number: 11414327
• Product Code: LPH
• UDI-Device Identifier: 10603295013334
• UDI-Public: 10603295013334
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2020

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: 1219-28-058
• Device Catalogue Number: 121928058
• Device Lot Number: 559076
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 09/21/2020; 12/14/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 10/15/2020; 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICUL/EZE BALL 28+1.5 GR; PINN SECTOR HA ACET CUP 58MM; ARTICUL/EZE BALL 28+1.5 GR; PINN SECTOR HA ACET CUP 58MM
• Outcome Attributed to Adverse Event: Required Intervention