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

Catalog Number UNK HIP FEMORAL STEM

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

Patient Problems Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)

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, "fourth-generation ceramic-on-ceramic total hip arthroplasty in patients of 55 years or younger: short-term results and complications analysis" written by wang weiguo, guo wanshou, yue debo, shi zhencai, zhang nianfei, liu zhaohui, sun wei, wang bailiang and li zirong published by chin med j 2014;127 (12) doi:10.3760/cma.J.Issn.0366-6999.20133349 on 2014 was reviewed for mdr reportability.The article reports on results of 132 cases (177 hips) who received coc bearing hip implants between january 2010 and december 2012.All patients receive depuy pinnacle cups with ceramic heads and liners and depuy summit stems in 30 hips and 147 hips with corail stems.The article captures 6 individual cases with patient identifiers in table 1 of complications.Generalized results were incidental inguinal pain found in 3 hips and thigh pain in 11 hips but no osteolysis or loosening of implants.Each patient is captured individually on linked complaints.This complaint captures no 3 a (b)(6) year old male with summit stem that experienced a femoral fracture 2 weeks post initial operation after a fall when standing up from a seat (all implants were stable) and received treatment of open reduction and internal fixation.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6107428552
• MDR Report Key: 9209677
• MDR Text Key: 174804941
• Report Number: 1818910-2019-108962
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2019
• 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
• Patient Age: 47 YR