MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SROM MAR LNR L 32MM+3MM 10 DEG; S-ROM HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122072332
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Not Applicable (3189)
Date of Event	07/02/2018
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
The patient was revised to address dislocation.It was also indicated that the patient had a depuy srom primary stem and ztt2 shell implanted.The surgeon remove the shell, liner and head.Doi: unknown; dor: (b)(6) 2018; right hip.
Additional Manufacturer Narrative
Pc-(b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch will be filed as appropriate.

• Brand Name: SROM MAR LNR L 32MM+3MM 10 DEG
• Common Device Name: S-ROM HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7719164
• Report Number: 1818910-2018-65183
• Device Sequence Number: 19099102
• Product Code: LPH
• UDI-Device Identifier: 10603295015918
• UDI-Public: 10603295015918
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K924492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2018

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: 122072332
• Device Lot Number: 7807323
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 08/28/2018
• 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: PIN LOCK, 5.0MM, PIN LOCK 5.0MM, UNKNOWN CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR