MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 ULTAMET 28MM HEADS +3; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Catalog Number 962702100

Device Problems Corroded (1131); Degraded (1153)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); No Code Available (3191)

Event Date 06/05/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The primary surgery was performed on (b)(6) 2013 via tha for the patient¿s left hip joint.There was no problem at the primary surgery.After the primary surgery, the patient stayed with instructor of ballet and there was aggressive joint activity.It was reported that the patient was diagnosed as having tumorous lesionhad when she was seen in another branch (not orthopedics) because the patient had a pain in the abdomen in 2020.The revision surgery was performed on (b)(6) 2020 by removing the tumor and replacing the liner (p/n: 121889150), the stem (p/n: 962702100) and the head (p/n: 900530210).The cup and the stem¿s sleeve were remained.The surgery was completed with about 2 hours.It was unknown whether there was any surgical delay.The surgeon confirmed that there was extensively pseudotumor around the patient¿s left hip joint.The patient did not have primary pain due to pseudotumor.The surgeon commented that there was a suspicion of armd.He requested analysis of component of the implants because the tarnishing was seemed at the neck of the stem and the head¿s connection.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).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.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

Manufacturer Narrative

Product complaint # (b)(4).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.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.H10 additional narrative: added: e1.Corrected: g1 (country code), h5, h6 (device).

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.H10 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : update 6-may-2021: the investigation was re-opened upon receipt of the device.Examination of the returned device confirmed the reported event of taper corrosion.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: 9/10 ULTAMET 28MM HEADS +3
• Type of Device: SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 10162584
• MDR Text Key: 195399951
• Report Number: 1818910-2020-13973
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K002883
• 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,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 962702100
• Device Lot Number: 3302041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9/10 ULTAMET 28MM HEADS +3; PINNACLE MTL INS NEUT28IDX50OD; SROM 9/10 16X10X130 36; 9/10 ULTAMET 28MM HEADS +3; PINNACLE MTL INS NEUT28IDX50OD; SROM 9/10 16X10X130 36
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 55