MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN LNR CON +4 NEUT 40IDX62OD; HIP ACETABULAR INSERT/LINER

Model Number	1218-40-662
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); Discomfort (2330)
Date of Event	11/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.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
Patient was revised due to suspected infection.Update jun 05, 2017: legal medical records received.Pfs alleges pain, discomfort, dislocation, limp, disfigurement, physical limitations and loss of enjoyment of life.After review of the medical records for mdr reportability, patient underwent incision and drainage secondary to periprosthetic infection.Examination notes stated that 1 week prior to i&d, fluid was aspirated from his hip estimated at 200 ml and sent to the laboratory.The cell count from that fluid was very high with a very high white count, indicative of an infection.1 week after i&d, patient was taken back to the operating room for a re-closure of wound dehiscence with wound drainage.3 months post revision surgery, patient experienced swelling and increase pain.It was revealed that white cell count was high.Intraoperative notes noted a large amount of brown material and cloudy in nature.There were some areas of necrosis that were debrided and extensive areas of granulation.There were also small areas of residual metallosis from the previous surgery.Changing of poly constrained liner was made due to continued impingement of the patient's femoral neck.It was also stated in the operative notes that the revision surgery was certainly a contributor to the infection.A secondary contributor was the amount of loss soft tissue and the reaction of the metal debris.A third factor was the history of posttraumatic disease.Lot numbers were provided.This complaint was updated on jun 12, 2017.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Ppf alleges elevated metal ions and abductor muscle repair.
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 LNR CON +4 NEUT 40IDX62OD
• Common Device Name: HIP ACETABULAR INSERT/LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6680695
• Report Number: 1818910-2017-20514
• Device Sequence Number: 10818030
• Product Code: KWZ
• UDI-Device Identifier: 10603295012184
• UDI-Public: 10603295012184
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2017

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 Expiration Date: 07/31/2020
• Device Model Number: 1218-40-662
• Device Catalogue Number: 121840662
• Device Lot Number: 681590
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 02/21/2019; 12/10/2020
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 02/22/2019; 12/10/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 91