MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP IMPLANT

Catalog Number UNK HIP

Device Problem Loss of Osseointegration (2408)

Patient Problems Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646); Limited Mobility Of The Implanted Joint (2671)

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.Reporter is an attorney.

Event Description

Patient has suffered significant discomfort, pain, stiffness and, upon information and belief, loosening of the hip, all of which results in difficult and painful mobility and ambulation, all of which is ongoing, and has, or is at risk for, metal toxicity from this implant, and needs ongoing care and treatment.Update 1 may 2018: receipt of ppf and sticker sheets.There were no new allegations reported.Added patient's date of birth and lawyer in the associated contact.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.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.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.

• Brand Name: UNKNOWN HIP IMPLANT
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds IN LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380-0988 ; 6103142063
• MDR Report Key: 8023943
• MDR Text Key: 125646822
• Report Number: 1818910-2018-74004
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP
• Device Lot Number: AH4BY1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2019
• 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
• Patient Outcome(s): Required Intervention