MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*HEAD FEMRL ALUMINA 32+6; S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS

Model Number	52-8330
Medical Device Problem Codes	Degraded (1153); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inflammation (1932)
Date of Event	10/19/2020
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
Clinical adverse event received for adverse local tissue reaction/high cobalt level 5.3 mcg/l.Event is serious and is considered severe, event is definitely related to device and is definitely not related to procedure.Date of implantation: (b)(6) 2005, date of event (onset): (b)(6) 2020, (left hip).Treatment: hip revised on (b)(6) 2020, of head and liner.
Additional Manufacturer Narrative
Product complaint # : (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (medical device problem code).
Event or Problem Description
Revision operative notes dated (b)(6) 2020 indicated that the patient received a left total hip revision due to bearing wear of the articulating metal surface.Upon entering the joint, extensive chronic inflammation was encountered.Mild corrosion was identified on the femoral head and trunnion of the stem.The backside of the liner and topside of the cup showed brown-red metallosis.The liner and head were revised, cup and stem were noted to be well fixed, cleaned and left implanted.The surgery was completed without indication of complication by the surgeon.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot - a device history record (dhr) review, was not possible because the required lot code was not provided.

• Common Device Name: S-ROM FEMORAL HEADS (11/13) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10905468
• Report Number: 1818910-2020-25491
• Device Sequence Number: 545508
• Product Code: LZO
• UDI-Device Identifier: 10603295171485
• UDI-Public: 10603295171485
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K011533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020

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: 52-8330
• Device Catalogue Number: 528330
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 12/08/2020; 01/04/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/12/2020; 01/05/2021
• 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: APEX HOLE ELIM POSITIVE STOP.; PINNACLE 100 ACET CUP 58MM.; S-ROM*HEAD FEMRL ALUMINA 32+6.; S-ROM*SLVE ZTTOVSZ 24F-LRG22ID.; SROM STM STD 36+12L 17X22.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 113