MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 28IDX48OD; HIP ACETABULAR INSERT/LINER

Catalog Number	121928048
Medical Device Problem Codes	Disassembly (1168); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
The patient was revised to address disassociation.
Additional Manufacturer Narrative
(b)(4).Investigation summary: conclusion and justification status: the complaint states the patient was revised to address disassociation.A review of complaint databases identified previous complaints due to implant dislocation and disassociation however a lot specific search or review of manufacturing records could not be conducted as no lot numbers were received.The complaint was transferred to bioengineering to comment on and the following statement was received; it is not possible to draw any conclusions from this complaint as no product has been returned, no lot numbers are available, and no other documentation such as medical records, x-rays or images are available for review at the time of writing.Post market surveillance is per sep-419.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.Post market surveillance is per sep 419.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
Complaint description: the patient was revised to address disassociation.

• Brand Name: PINN MAR NEUT 28IDX48OD
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6948867
• Report Number: 1818910-2017-26542
• Device Sequence Number: 1141784
• Product Code: LPH
• UDI-Device Identifier: 10603295013280
• UDI-Public: 10603295013280
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K000306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2017

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 Catalogue Number: 121928048
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 03/02/2018
• 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: Hospitalization; Required Intervention