MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BIOSTOP G CEM RESTR 12MM; CEMENT CENTRALIZER/PLUG

Catalog Number	546312000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).B5 additional event information: implants removed and cement spacer implanted.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, depuy synthes, 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.
Event or Problem Description
Removal of all delta xtend implants due to infection.Surgeon did original operation in 2020 and first revision 2 months later for dislocation.No surgical delay.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: it was reported, that removal of all delta extend implants, due to infection.Surgeon did original operation in year.And first revision 2 months later for dislocation.The product was not returned to depuy synthes.However, photos were provided for review.The photo investigation revealed, nothing indicative of a device nonconformance.Since, the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed.As the observed, condition of the biostop g cem restr 12mm would not contribute to the reported adverse event.Based on the investigation findings, it has been determined, that no corrective and/or preventative action is proposed.There is no indication, that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: BIOSTOP G CEM RESTR 12MM
• Common Device Name: CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CMW MFG & MATERIAL WAREHOUSE
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18717396
• Report Number: 1818910-2024-03190
• Device Sequence Number: 15030295
• Product Code: JDK
• UDI-Device Identifier: 10603295174561
• UDI-Public: 10603295174561
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K943727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: 04/30/2021
• Device Catalogue Number: 546312000
• Device Lot Number: 18E1503016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DXTEND GLENOSPHERE ECC D38MM; DXTEND HUMERAL SPACER +9MM; DXTEND MBLOC HUM EPI 1 D12 STD; DXTEND METAGLENE; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW LOCK D4.5X30MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND SCREW NO LOCK D4.5X18MM; DXTEND STAND PE CUP D38 +3MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female