MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DELTA MODULAR HEAD 40MM; DELTAMOTION : HIP CERAMIC FEMORAL HEADS

Catalog Number 167140F

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Joint Disorder (2373); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 12/14/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).

Event Description

Product fracture after implantation.

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.The previous device code (fracture) is being retracted as it was further identified that the product is not fractured.Investigation summary: the devices were reviewed by bioengineering and a report was received stating; it was unlikely that a manufacturing defect was present.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.A review of complaint databases did not identify any anomalies.The device was reviewed by bioengineering and a report was received stating; with regards to the had a goldberg taper score of 1 was given, stripe wear and wear scar noted, 1-24% of fine scratches identified and 1-5% of metallic transfer.With regards to the liner; no impingement or malalignment noted, metallic transfer of 1-5% identified on the bearing surface.With regards to the shell; 6-25% of bone/organized soft tissue was noted on the fixation surface and goldberg taper score of 1 was given.With regards to the stem; on the fixation surface 6-25% of bone/organized soft tissue was noted, and 51-100% ha was absent from the fixation surface.On the taper of the stem a goldberg taper score of 1 was given for the stem (head), and 1 for the sleeve.The actual date of implantation is not mentioned in the complaint.No x-ray's or medical records available for review.The implant components (stem, ceramic head, ceramic liner, cup, sleeve fitted on the stem) received were reviewed for any damage or fracture.No fracture observed in any returned components.Retrieval marks noticed on the stem and cup.The stem taper has damage marks which is potentially a retrieval damage.The liner is presented as a separate piece from the cup suggestive of disassociation of the liner however based on the data available no conclusions can be provided.The mode of failure of the prosthesis is multi-factorial and consideration has to be given to all other potential influences such as surgical process, patient variables e.G.Activity, weight, bmi and use, anatomical considerations and patient changes over time.This report details the findings from a review of the products returned and information as supplied at the time of evaluation.Any conclusions from this data have to be placed into context with all other relevant factors.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is (b)(4).Device history lot: null.Device history batch: null.Device history review: null.

Event Description

Additional information received: after the investigation of the returned products, it was identified that none of these are fractured, chipped or cracked.

Manufacturer Narrative

Product complaint #: (b)(4).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.Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Corrective action was not indicated.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information received indicating that 79 months after tha, the patient had thigh pain, limping and hardly reproducible squeaking.Macro instability of corail stem.During revision, a moderate coloring of surround soft tissues in black (titanium granulomas) was noted.Aspiration and microbial cultures were negative.Leukocyte esterase test was negative.The stem was macro unstable.The insert was dissociated from the cup and easily came out during its extraction.

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.H10 additional narrative: investigation summary: the devices were reviewed by bioengineering and a report was received stating; it was unlikely that a manufacturing defect was present.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.A review of complaint databases did not identify any anomalies.The device was reviewed by bioengineering and a report was received stating; with regards to the had a goldberg taper score of 1 was given, stripe wear and wear scar noted, 1-24% of fine scratches identified and 1-5% of metallic transfer.With regards to the liner; no impingement or malalignment noted, metallic transfer of 1-5% identified on the bearing surface.With regards to the shell; 6-25% of bone/organized soft tissue was noted on the fixation surface and goldberg taper score of 1 was given.With regards to the stem; on the fixation surface 6-25% of bone/organized soft tissue was noted, and 51-100% ha was absent from the fixation surface.On the taper of the stem a goldberg taper score of 1 was given for the stem (head), and 1 for the sleeve.The actual date of implantation is not mentioned in the complaint.No x-ray's or medical records available for review.The implant components (stem, ceramic head, ceramic liner, cup, sleeve fitted on the stem) received were reviewed for any damage or fracture.No fracture observed in any returned components.Retrieval marks noticed on the stem and cup.The stem taper has damage marks which is potentially a retrieval damage.The liner is presented as a separate piece from the cup suggestive of disassociation of the liner however based on the data available no conclusions can be provided.The mode of failure of the prosthesis is multi-factorial and consideration has to be given to all other potential influences such as surgical process, patient variables e.G.Activity, weight, bmi and use, anatomical considerations and patient changes over time.This report details the findings from a review of the products returned and information as supplied at the time of evaluation.Any conclusions from this data have to be placed into context with all other relevant factors.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.Device history lot: null.Device history batch: null.Device history review: null.

• Brand Name: DELTA MODULAR HEAD 40MM
• Type of Device: DELTAMOTION : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8335003
• MDR Text Key: 136003609
• Report Number: 1818910-2019-84320
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/24/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 167140F
• Device Lot Number: 119042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 03/01/2019; 07/29/2019; 08/20/2019
• Supplement Dates FDA Received: 03/08/2019; 08/12/2019; 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention