MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP FEMORAL HEAD METAL; METAL FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD METAL

Device Problem Noise, Audible (3273)

Patient Problems Ossification (1428); Adhesion(s) (1695); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Discomfort (2330); Joint Laxity (4526); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical records received.After review of medical records, it was indicated that patient had a left hip tha and was revised due to polyethylene wear status post remote left thr.X-ray evidence of some poly wear which was confirmed at the time of operation.There was some mild granulation tissue associated with poly wear and chronic synovitis.Exchanged of liner and head.Clinic visits reported of clicking, pain, small effusion, synovial thickening, bursitis, stiffness, laxity on left hip, discomfort with certain movements and heterotopic ossification.Doi: (b)(6) 1998, dor: (b)(6) 2017, left hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A singular x-ray image was provided for review.It is noted the patient has had bi-lateral hip replacement.This report involves the left hip.The femoral head is well centered within the cup/liner construct.Nothing indicative of a product problem identified.The information received will be retained for potential series investigations if triggered by trend analysis 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: a device history record (mre) review, was not possible because the required lot code was not provided.

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.

Event Description

Medical records were received: the medical records, contained some spinal procedures, not relevant to depuy synthes products.The records did indicate, that a revision for polywear was performed on (b)(6) 2017.Scarring, pseudocapsule, and mild granulation tissue were identified upon entry.The polywear was confirmed, intraoperatively as well.

• Brand Name: UNK HIP FEMORAL HEAD METAL
• Type of Device: METAL FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12487733
• MDR Text Key: 271884354
• Report Number: 1818910-2021-20388
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL HEAD METAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 10/18/2021; 07/20/2023
• Supplement Dates FDA Received: 10/19/2021; 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNK HIP ACETABULAR CUP SROM; UNK HIP ACETABULAR LINER POLY SROM; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNKNOWN HIP FEMORAL STEM; ZIRCONIA HEAD; UNK HIP ACETABULAR CUP SROM; UNK HIP ACETABULAR LINER POLY SROM; UNK HIP BONE SCREW; UNK HIP BONE SCREW; UNKNOWN HIP FEMORAL STEM; ZIRCONIA HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male