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

Model Number	1220-70-128
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/19/2021
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that this patient had her hip replaced 20+ years ago, the surgeon and hospital where the original primary hip took place is unknown.Dr.(b)(6) revised this patient's hip on (b)(6) 2021 for a worn out acetabular liner.The patient did fine until recently according to dr.(b)(6) but has dislocated several times after bending into a position trying to catch an item falling.What the item and position are unknown.The surgeon revised the hip and explanted the liner and replaced it with a constrained liner and the supercup was left in vitro.The stem and hip ball are not a depuy product.This is all of the information available to me at this time.Doi: (b)(6) , 2021 dor: (b)(6) 2021 affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Examination of the singular provided x-ray image does not depict a dislocation event.The femoral head is well centered within the cup/liner construct.Nothing indicative of a product problem is identified.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 material, manufacturing, inspection or sterile processing that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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 US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12137973
• Report Number: 1818910-2021-14724
• Device Sequence Number: 11706018
• Product Code: LPH
• UDI-Device Identifier: 10603295015840
• UDI-Public: 10603295015840
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K924492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2021

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: 1220-70-128
• Device Catalogue Number: 122070128
• Device Lot Number: 8540210
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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: COMPETITOR HIP BALL/HEAD; COMPETITOR STEM; SROM MARATHON LINER M 28 10DEG; SUPERCUP; COMPETITOR HIP BALL/HEAD; COMPETITOR STEM; SROM MARATHON LINER M 28 10DEG; SUPERCUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR