MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK CEMENT RESTRICTOR/PLUG

Model Number	1294-18-610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/15/2020
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
Surgeon planned for a right hip revision of a (b)(6) yrs old female.Patient had a p.F.C.Cemented hip, a pfc cup, pfc liner, 28+0 head and 2 screws.All removed and replaced with a revision.Had we been able to source a replacement pfc acetabular liner and all 28 and 32 pfc head options, this surgery would have taken 30 minutes instead of 4 hours.The surgeon was aware of the limited availability and his plan a if everything went well was just to change the pfc head with a 32+0 option (only one available) and a multi hole gription cup with a 32 altrx liner.However, patient was more unstable than expected so the surgeon removed the stem&cement, removed cup, liner, screws and head.Replaced with a stryker dm cup and a long cemented exeter.
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.No code available (3191) is used to capture surgery prolonged.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNK CEMENT RESTRICTOR/PLUG
• Common Device Name: CEMENT RESTRICTOR/PLUG
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10756517
• Report Number: 1818910-2020-23564
• Device Sequence Number: 3333976
• Product Code: NJL
• UDI-Device Identifier: 10603295024293
• UDI-Public: 10603295024293
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• 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,Followup,Followup
• Report Date (Section B): 10/15/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1294-18-610
• Device Catalogue Number: UNK CEMENT RESTRICTOR/PLUG
• Device Lot Number: 129418,50208143
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 10/29/2020; 01/07/2021; 02/02/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/10/2020; 01/13/2021; 02/02/2021
• 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: 12MM NON-POROUS DISTAL CENTRAL; P.F.C.* 28MM HEAD +0MM; P.F.C.*LINER 48-52/10DEG-28; P.F.C.*NONPOROUS STEM #2; PFC*POR SHELL/MULTIHOLE SZ50MM; UNK HIP BONE SCREW; UNK HIP BONE SCREW; 12MM NON-POROUS DISTAL CENTRAL; P.F.C.* 28MM HEAD +0MM; P.F.C.*LINER 48-52/10DEG-28; P.F.C.*NONPOROUS STEM #2; PFC*POR SHELL/MULTIHOLE SZ50MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR