MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL STEM

Catalog Number UNK HIP FEMORAL STEM

Device Problem Loss of Osseointegration (2408)

Patient Problems Bone Fracture(s) (1870); Unspecified Infection (1930); Pain (1994); Skin Irritation (2076); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 05/02/2019

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.(b)(4).

Event Description

The literature article entitled, "declining revision burden of metal-on-metal hip arthroplasties" written by olli s.Lainiala, md, phd, aleksi p.Reito, md, phd, jyrki j.Nieminen, md, phd, and antti p.Eskelinen, md, phd published by the journal of arthroplasty made available online on 2 may 2019 was reviewed.The article's purpose was to report the survivorship for various stemmed metal on metal total hip arthroplasties and hip resurfacings for both primary and revision surgeries in one of the world's largest single-institution mom hip arthroplasty cohorts and to describe the reasons and temporal trends for revisions and to analyze risk factors for revisions.It is noted that depuy products were listed in the data set with other non-depuy products.Cement manufacturer is not identified for resurfacings.The article provides a list of indications for revision but does not clarify which specific products are associated with each type of revision reason.Therefore, accurate quantities cannot be determined in this complaint based upon the limited information provided by the article.Depuy products: asr head, asr cup, asr xl head, asr xl cup, asr xl sleeve (augment), pinnacle cup, metal liner, metal head, srom stem, srom sleeve (augment).Revision reasons: armd attributed to bearing wear, infection, femoral periprosthetic fracture and femoral neck fracture and trochanteric fracture, femoral loosening, acetabular loosening, "loosening of mom liner", multiple dislocations/instability, impingement, acetabular fracture, osteolysis of femoral neck, malposition of cup component, acetabular osteolysis, unexplained pain, rash.

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.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.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10313854
• MDR Text Key: 200445103
• Report Number: 1818910-2020-16654
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention