MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN MULTIHOLE W/GRIPTION 60MM; HIP ACETABULAR CUP

Model Number	1217-30-060
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Bone Fracture(s) (1870); Hematoma (1884); Necrosis (1971); Pain (1994); Anxiety (2328); Hip Fracture (2349); Not Applicable (3189)
Date of Event	06/27/2017
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 acetabular fracture.
Additional Manufacturer Narrative
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.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
Litigation alleges constant pain, metallosis, anxiety, fear and cobalt/chromium poisoning.
Event or Problem Description
Pfs and medical records received.Pfs has no new allegation.After review of medical record for mdr reportability, the patient was revised to address fracture of the acetabular with internal fixation.
Event or Problem Description
Pps and medical records received.There is no new allegation.After review of medical records for the mdr reportability, patient was revised to address fracture of left acetabulum.Revision notes reported of large hematoma, extensive tissue necrosis and pseudotumor from his metal debris.One screw was removed and one of the screws is broken and this screw was left in the bone.Surgeon felt that it would be too difficult to remove acetabular bone to get this screw out.Clinical notes reported of dislocation and acetabular fracture.
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN MULTIHOLE W/GRIPTION 60MM
• Common Device Name: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6736871
• Report Number: 1818910-2017-21660
• Device Sequence Number: 1286336
• Product Code: LPH
• UDI-Device Identifier: 10603295010029
• UDI-Public: 10603295010029
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K071784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/27/2017

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: 05/31/2025
• Device Model Number: 1217-30-060
• Device Catalogue Number: 121730060
• Device Lot Number: 667689
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 08/22/2017; 02/01/2018; 03/22/2018; 05/17/2018; 06/27/2019; 03/17/2020
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 08/22/2017; 02/14/2018; 04/05/2018; 05/22/2018; 07/05/2019; 04/08/2020
• 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: 73 YR