MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 9/10 COCR HEAD 28MM -3; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Model Number	1521-90-057
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Discomfort (2330); Joint Dislocation (2374); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 primary surgery was performed on (b)(6) 2007 via tha for the patient¿s right hip joint.It was reported that the patient had uncomfortable feeling at her right hip joint, and the surgeon suspected the dislocation of the liner (p/n: 121828048) by x-ray.The revision surgery was performed on (b)(6) 2020 by replacing the liner, the stem (p/n: 900535210), the head (p/n: 152190057).During the surgery, the surgeon found that the metallosis occurred due to the liner¿s wear and the dislocation, and there was tissue like pseudotumor.The revision surgery was completed, and it was unknown whether there was any surgical delay.The patient is under observation.The surgeon commented that the background of the liner¿s dislocation was unclear.No further information is available.
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 reported incident(s) against the provided product/lot combination(s) since release for distribution.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.Corrective action was not indicated.

• Brand Name: 9/10 COCR HEAD 28MM -3
• Common Device Name: SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10290964
• Report Number: 1818910-2020-16186
• Device Sequence Number: 860319
• Product Code: JDI
• UDI-Device Identifier: 10603295276623
• UDI-Public: 10603295276623
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2020

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: 1521-90-057
• Device Catalogue Number: 152190057
• Device Lot Number: 2299879
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 09/04/2020
• 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: 9/10 COCR HEAD 28MM -3; PINN LINER NEUT 28IDX48OD; S-ROM*SLEEVE PRX ZTT, 18B-LRG; SROM 9/10 18X13X140 30
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR