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

Catalog Number 546312000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 02/06/2024

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 335523147
• Report Number: 1818910-2024-03190
• Device Sequence Number: 1
• Product Code: JDK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K943727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female