MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 9/10 ULTAMET 36MM HEADS -3; SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS

Catalog Number 962710000

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

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/16/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

It was reported that the patient underwent the revision tha surgery on (b)(6) 2021.In the surgery, soft tissue degeneration and black powder around the neck and head interdigitation were confirmed.All the implants except a sleeve were removed.The cup was completely loose with no evidence of biological fixation.The adverse health effects due to this event were pain around the hip joint, discomfort, mental instability, and decreased hip function due to soft tissue degeneration.The doctor commented that the occurrence of reactive pseudotumor was due to artificial joint.This new information causes the removed depuy components to go from non reportable to reportable as they have been revised.The femoral head/stem were noted to have black powder (corrosion), the liner/head were the articulating surfaces and are being reported for the pseudotumor and soft tissue degeneration.The pain and discomfort may be attributed to the loosening and pseudotumor.The acetabular cup was noted to be a competitor cup.

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.Device history lot : the alleged adverse symptoms, and the product code reported, are associated with the articulation between depuy metal-on-metal products.Per wi-3430, it has been determined that should additional reports be identified for related metal-on-metal complications, a device history record (dhr) review is not required.Therefore, a complaint database search and/or device manufacturing review will not be performed for the reported product associated with this investigation.

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.Device history lot : the alleged adverse symptoms, and the product code reported, are associated with the articulation between depuy metal-on-metal products.Per wi-3430, it has been determined that should additional reports be identified for related metal-on-metal complications, a device history record (dhr) review is not required.Therefore, a complaint database search and/or device manufacturing review will not be performed for the reported product associated with this investigation.

• Brand Name: 9/10 ULTAMET 36MM 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
• Manufacturer (Section G): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12712220
• MDR Text Key: 278824476
• Report Number: 1818910-2021-23907
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K982918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2021

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 Catalogue Number: 962710000
• Device Lot Number: 3126267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 11/10/2021; 11/25/2021
• Supplement Dates FDA Received: 11/11/2021; 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2010
• 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: 9/10 ULTAMET 36MM HEADS -3; COMPETITORS; PINNACLE MTL INS NEUT36IDX60OD; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM 9/10 18X13X140 36+8; 9/10 ULTAMET 36MM HEADS -3; COMPETITORS; PINNACLE MTL INS NEUT36IDX60OD; S-ROM*SLEEVE PRX ZTT, 18D-LRG; SROM 9/10 18X13X140 36+8
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 84 KG