MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ARTICUL/EZE BALL 32 +13 BLK; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Model Number	1365-24-000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Joint Dislocation (2374)
Date of Event	05/04/2022
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
Patient underwent primary thr on (b)(6) 2019 where a corail pinnacle was implanted.As per the notes, the patient dislocated 2 times and was then brought back to theatre on (b)(6) 2019 where the pinnacle liner was exchanged to a constrained liner and a longer femoral head implanted.Patient has now presented with pain with a the x ray showing the hip to be dislocated.According to the patient, his hip has never been right and he has suffered with pain since the original index surgery.The x ray images show a dislocated hip, locking ring around the neck and the ring that locks the poly into the shell, broken and lying in the surrounding soft tissue.On opening the hip, backend soft tissue was evident, the poly locking ring was located, bent and broken and the poly liner was found exerted in the soft tissue and not in the shell.The blackened tissue was removed, the liner removed.A new constrained liner was implanted and a head without a ¿skirt¿ implanted (the previous head ad a skirt and would have resulted in more impingement) only the products removed in this surgery have been listed.Doi: (b)(6) 2019.Dor: (b)(6) 2022.Right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this complaint was not received for examination.The photo investigation and review of the x-rays provided revealed dislocation of the head and liner.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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mrae) was not performed.

• Brand Name: ARTICUL/EZE BALL 32 +13 BLK
• Common Device Name: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14461181
• Report Number: 1818910-2022-09287
• Device Sequence Number: 4699729
• Product Code: JDI
• UDI-Device Identifier: 10603295033202
• UDI-Public: 10603295033202
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K883460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 1365-24-000
• Device Catalogue Number: 136524000
• Device Lot Number: D15062132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICUL/EZE BALL 32 +13 BLK; PINN LNR CON +4 10D 32IDX62OD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male