MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SROM MARATHON LINER M 28 10DEG; S-ROM HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122070128
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
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
Revision hip: unknown primary details: this case is logged to capture 1st revision: we had a surgeon replace a liner 122070128 s-rom marathon liner m 28 10 degree non-constrained into an s-rom 51mm oblong shell.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: SROM MARATHON LINER M 28 10DEG
• Common Device Name: S-ROM HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7613516
• Report Number: 1818910-2018-62564
• Device Sequence Number: 19178149
• Product Code: LPH
• UDI-Device Identifier: 10603295015840
• UDI-Public: 10603295015840
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K924492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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: 122070128
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 08/02/2018
• 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: Required Intervention