MAUDE Adverse Event Report: DEPUY INTL.,LTD 8010379 ARTICUL/EZE BALL 32 +5 BR; HIP FEMORAL HEAD

Catalog Number 136522000

Device Problems Metal Shedding Debris (1804); Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Ambulation Difficulties (2544); No Code Available (3191); Unspecified Tissue Injury (4559); Physical Asymmetry (4573)

Event Date 02/23/2015

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation alleges patient was revised to address pain, discomfort, metallosis, metal debris, popping and a cracked poly liner.

Manufacturer Narrative

No device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Udi: (b)(4).

Event Description

Update jun 19, 2017: legal medical records received.In addition to what was previously alleged, pfs alleges differing leg length and difficulty walking.After review of the medical records for mdr reportability, it was stated that the patient was revised to address polyethylene failure.Revision note stated fracture in the polyethylene and significant metallosis in the soft tissues.Part and lot information were updated.This complaint was updated on: jul 3, 2017.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Additional information received indicated that in addition to what previously alleged, ppf alleged metal wear.Pfs alleged difficulty in walking.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.E3 initial reporter occupation: lawyer.

• Brand Name: ARTICUL/EZE BALL 32 +5 BR
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY INTL.,LTD 8010379; st. anthony's rd; leeds, leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 6499668
• MDR Text Key: 73018771
• Report Number: 1818910-2017-16568
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K843909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/23/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: 136522000
• Device Lot Number: D09090696
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/23/2017
• Initial Date FDA Received: 04/18/2017
• Supplement Dates Manufacturer Received: Not provided; 06/19/2017; 02/12/2021; 08/18/2021
• Supplement Dates FDA Received: 05/15/2017; 07/05/2017; 02/14/2021; 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX +4 10D 32IDX50OD; COMPETITOR LCP PLATE; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINNACLE SECTOR II CUP 50MM; SYNTHES SUSA-M SCREWS; TRI-LOCK BPS SZ 3 HI OFFSET
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 79