MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DELTA MODULAR SLEEVE 12/14 L; DELTAMOTION : HIP FEMORAL AUGMENT

Catalog Number 167062F

Device Problem Degraded (1153)

Patient Problems Foreign Body Reaction (1868); Pain (1994)

Event Date 12/16/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient underwent primary thr where a trilock stem and delta motion acetabular cup was utilized.Patient has presented with hip pain.Images attached show metalosis.On opening the hip, the taper on the stem was found to be damaged (tunionosis).Quote on surgeons text message as i was not present, "was the trunion.Was damaged with a well fixed stem.Disaster." delta motion acetabular component and trilock stem were removed and a zimmerbiomet implant implanted.No further details are available.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this complaint was not returned.Photo and mri evidence provided, however we are only trained to review what was provided as photo evidence.There was not enough information that would suggest the presence of implant corrosion.The reported condition was not confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product code/lot code combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Investigation summary
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> the device associated with this complaint was not returned.A photo was provided for review.There was no evidence that would suggest the presence of implant corrosion.The reported condition was not confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot
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> a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product code/lot code combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: DELTA MODULAR SLEEVE 12/14 L
• Type of Device: DELTAMOTION : HIP FEMORAL AUGMENT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16162429
• MDR Text Key: 307719742
• Report Number: 1818910-2023-01206
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 167062F
• Device Lot Number: 108143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DELTA MODULAR HEAD 44MM; DELTA MODULAR SLEEVE 12/14 L; DM ACETABULARCUP56MM/44MMHEAD; TRI-LOCK BPS SZ 6 HI OFFSET
• Patient Sex: Male