MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SCREW,6.5MM DIA,20MM LG; BONE SCREWS AND PINS : SCREWS

Model Number	55-6071
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).(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) 2009, the primary surgery was performed via tha for right hip with the implants.On (b)(6) 2021, the revision surgery was performed because the cup fixation was lost and the acetabular was hardly damaged.In the revision, it was found that the corrosion at the neck had occurred and there was pseudotumor due to this corrosion.The surgeon couldn¿t remove the stem and it was left in the patient.He removed the head, insert and cup (other company's product).The revision surgery was completed successfully.The patient is rehabilitating of walking training.The surgeon commented that the pseudotumor was caused by the wear between insert and head, and the corrosion between the stem and head.We went attention to the sales rep to comply with the prescribed reporting date.No further information is available.Doi: (b)(6) 2009: dor: (b)(6) 2021, right 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.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: 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Common Device Name: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11705862
• Report Number: 1818910-2021-08389
• Device Sequence Number: 14207735
• Product Code: LPH
• UDI-Device Identifier: 10603295175919
• UDI-Public: 10603295175919
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 03/17/2021

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: 55-6071
• Device Catalogue Number: 556071
• Device Lot Number: 0486071F
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 05/19/2021
• 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: 9/10 ULTAMET 36MM HEADS +6.; PINN-A MULTIHOLE ACET CUP 52MM.; PINNACLE MTL INS NEUT36IDX52OD.; S-ROM*SCREW,6.5MM DIA,15MM LG.; S-ROM*SCREW,6.5MM DIA,15MM LG.; S-ROM*SCREW,6.5MM DIA,20MM LG.; S-ROM*SCREW,6.5MM DIA,20MM LG.; UNKNOWN HIP FEMORAL STEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR