MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 CEMENTRALIZER 12.0; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG

Model Number	1376-21-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Chills (2191); Diaphoresis (2452); No Code Available (3191); Swelling/ Edema (4577)
Date of Event	05/24/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Representing surgical intervention.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
Pending product liability, customer alleges infection after first revision.
Additional Manufacturer Narrative
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, post market surveillance, 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.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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, post market surveillance, 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.Replaced surgical intervention with medical device removal.
Event or Problem Description
In additional to what were previously alleged, pfs alleges difficulty moving, sitting, standing and bending.After review of medical records, patient complaints of pain , episodes of sweating and then chills.Patient was diagnose with acute blood loss anemia and 2 units prbc was given on 1/15/2013.The patient was then revised for removal of antibiotic spacers.Operative notes reported that the fascia was very scarred down and adherent to the soft tissue.There was fair amount of fluid on the hip.
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.H10 additional narrative: added: b5, b6, b7 and h6 (clinical codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: a1.

• Brand Name: CEMENTRALIZER 12.0
• Common Device Name: HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7919773
• Report Number: 1818910-2018-70841
• Device Sequence Number: 19409515
• Product Code: LTO
• UDI-Device Identifier: 10603295034452
• UDI-Public: 10603295034452
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K871510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/05/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 1376-21-000
• Device Catalogue Number: 137621000
• Device Lot Number: 281967
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 10/04/2018; 07/20/2021; 08/04/2021
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 10/05/2018; 08/03/2021; 08/24/2021
• 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: ARTICUL/EZE BALL 32 +9 BL; CEMENTRALIZER 12.0; PINN CAN BONE SCREW 6.5MMX35MM; PROSTALAC ACET CUP 42X32; PROSTALAC RT 240 STEM SZ3; SMITH & NEPHEW CABLES & CLAMP; STRYKER CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR