MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 S-ROM*HEAD FEMORAL COCR 22+0; S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS

Model Number	52-2022
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/03/2021
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 on (b)(6) 2003, the patient underwent the tha surgery for left hip at another hospital.Although there was no particular problem after the surgery, the patient visited the hospital ((b)(6) hospital) because of repeated dislocation this year.On (b)(6) 2021, the patient underwent the revision surgery.In the revision surgery, a cup and a stem were replaced with new ones.Because the hospital didn¿t have the same product as the liner which had been implanted in stock, the liner was kept using as it was.When the surgeon checked the liner, the liner in the dislocated direction was broken.The surgeon commented that the breakage of the liner might be one of the causes of frequent dislocation.The revision surgery was completed with no problem.No further information is available.Doi: (b)(6) 2003, dor: (b)(6) 2021, left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination 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.Device history lot: a worldwide complaint database search found no additional related reports against the provided product code/lot number combination.Based on the inability to find any additional related reports against the provided product code/lot number combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 12519415
• Report Number: 1818910-2021-20912
• Device Sequence Number: 20080288
• Product Code: JDI
• UDI-Device Identifier: 10603295170778
• UDI-Public: 10603295170778
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K851422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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: 52-2022
• Device Catalogue Number: 522022
• Device Lot Number: 1074443
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 10/14/2021
• 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: S-ROM*CUP ACE,ZTT,PD-1,40MM; S-ROM*HEAD FEMORAL COCR 22+0; S-ROM*POLY DIAL LINR-PD-1; S-ROM*SCREW,3.5MM DIA,25 MM LG; S-ROM*SLEEVE PRX ZTT, 14B-LRG; S-ROM*STM STD,30NK 14X09X130; S-ROM*CUP ACE,ZTT,PD-1,40MM; S-ROM*HEAD FEMORAL COCR 22+0; S-ROM*POLY DIAL LINR-PD-1; S-ROM*SCREW,3.5MM DIA,25 MM LG; S-ROM*SLEEVE PRX ZTT, 14B-LRG; S-ROM*STM STD,30NK 14X09X130
• Outcome Attributed to Adverse Event: Required Intervention