MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 ASR ACETABULAR CUPS 48; ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS

Catalog Number 999800748

Device Problems Use of Device Problem (1670); Loss of Osseointegration (2408); Malposition of Device (2616); Naturally Worn (2988); Osseointegration Problem (3003)

Patient Problems Wound Dehiscence (1154); Cyst(s) (1800); Edema (1820); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tissue Damage (2104); Distress (2329); Impaired Healing (2378); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 11/01/2019

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.Occupation is a non-healthcare professional.(b)(4).

Event Description

Medical records received.After review of medical records, the patient was revised to address aseptic loosening, acetabular protusio, pseudotumor secondary to metal on metal reaction, rupture of adductor tendon mechanism and fascial dehiscence.Prior to being revised, patient reports pain.Workup elsewhere reveals a loose cup with acetabular protusio and rotation of the cup into a passive vertical position.Intraoperatively, a cystic mass was opened and there was milky, non-purulent fluid consistent with metal on metal disease.The abductors were repaired.It was confirmed that the acetabular component was loose and had rotated 90 degrees into the base of the acetabulum.Metal on metal metallic debris was found in the posterior acetabular wall as well as on the trunnion.Doi: (b)(6) 2009; dor: (b)(6) 2019 (right hip).

Manufacturer Narrative

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.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 : 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, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation alleges that the asr cup rotated out of position, large psuedotumor, dehiscence, 2/3 of the abductors were detached, metallic debris, protrusion acetabuli, metallosis, dropfoot, weakness, pain, discomfort, scarring, and other pain, emotional and physical suffering.

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: b5, d4 (udi), d10 and h6 (clinical codes).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: e1, e3, g1 and h6 (impact code).E3 initial reporter occupation: lawyer.

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 : device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.

• Brand Name: ASR ACETABULAR CUPS 48
• Type of Device: ASR HIP SYSTEM : HIP METAL ACETABULAR CUPS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 9490250
• MDR Text Key: 174906744
• Report Number: 1818910-2019-123803
• 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: other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Catalogue Number: 999800748
• Device Lot Number: 2821637
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1749/1816-2011
• Patient Sequence Number: 1
• Treatment: ADAPTER SLEEVES 12/14 +2; ASR UNI FEMORAL IMPL SIZE 43; TRI-LOCK BPS SZ 4 STD OFFSET
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR