MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ADAPTER SLEEVES 12/14 +5; ASR HIP SYSTEM : HIP FEMORAL SLEEVE

Catalog Number 999800315

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

Patient Problems Abscess (1690); Cellulitis (1768); Necrosis (1971); Sepsis (2067); Osteolysis (2377); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.Clinical code: (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

Asr revision.Litigation records received.Prior to revision patient alleges swelling, tenderness, redness and abnormal level of chromium.Mri revealed crescentic fluid collection along the lateral margin of the proximal femur with adjacent cellulitis and soft tissue swelling consistent with necrotizing fasciitis and abscess communicating with hip joint space.He underwent revision due to sepsis and infection.Doi: (b)(6) 2008.Dor: (b)(6) 2020.Right hip.

Event Description

In addition to what previously alleged pfs alleged osteolysis.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed andthe investigation will be re-opened as necessary.Update 01-sep-2021 received did not have any additional details to be added in investigation.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 : previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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 : previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

• Brand Name: ADAPTER SLEEVES 12/14 +5
• Type of Device: ASR HIP SYSTEM : HIP FEMORAL SLEEVE
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 12310071
• MDR Text Key: 266105471
• Report Number: 1818910-2021-17636
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: K040627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2021

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 Expiration Date: 09/14/2013
• Device Catalogue Number: 999800315
• Device Lot Number: 2744836
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 08/20/2021; 09/08/2021
• Supplement Dates FDA Received: 08/22/2021; 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ASR 300 SPIKED CUP SIZE 58; ASR UNI FEMORAL IMPL SIZE 51; SUMMIT DUOFIX TAP SZ8 HI OFF; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM; UNK HIP ACETABULAR CUP ASR; UNK HIP FEMORAL HEAD METAL ASR; UNK HIP FEMORAL SLEEVE ASR; UNKNOWN HIP FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 97