MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP IMPLANT

Catalog Number UNK HIP

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

Patient Problems Unspecified Infection (1930); Hypoesthesia (2352); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.(b)(4).This report addresses 6 instances of the same product.

Event Description

Literature article, entitled: "the c-stem in clinical practice fifteen-year follow-up of a triple tapered polished cemented stem", by bodo purbach, md, et.Al, published in the journal of arthroplasty 28 (2013) 1367¿1371, reviewed for mdr reportability.The study reports on experience with the triple tapered polished cemented stem, c-stem, which was based on the original charnley concept of the ¿flat back¿ polished stem.Four hundred and eighteen arthroplasties had a clinical and radiological follow-up past 10 years with a mean follow-up of 13 years (10¿15).There were no revisions for stem loosening but 2 stems were revised for fracture ¿ both with a defective cement mantle proximally.The stem design and the surgical technique support the original charnley concept of limited stem subsidence within the cement mantle and the encouraging results continue to stand as a credit to sir john charnley's original philosophy.A cemented all-poly depuy cup, paired with a depuy metal or ceramic 22.225-mm diameter head, was used in all cases, and the depuy c stem was used for all femoral stem components.Depuy bone cement was used for both cup and stem.Product and lot code specifics were not provided within the article, nor were patient specific identifiers.Including the previously noted femoral stem fractures, the following complications resulted, with revision surgeries as indicated in the following listing (some patients experienced more than one complication and some had more than one indication for each revision--these were not broken out in the article): reported complications (totals): infection - 7, dislocation - 8, aseptic loose cup - 45 (identified radiographically), fractured stem - 2.Reported revision surgeries (totals): infection - 5, dislocation - 2, aseptic loose cup - 24, fractured stem - 2, neuralgia paraesthetica - 1, bearing wear - 4.For purposes of reporting adverse events, the revised complications are captured within the unk hip implant, unk hip femoral head, unknown hip poly acetabular cups, unknown hip femoral stem, and the unknown bone cement impacted products.This report captures the unk hip implant.

Manufacturer Narrative

Product complaint # : (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.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 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.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, will be filed as appropriate.

• Brand Name: UNKNOWN HIP IMPLANT
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8226166
• MDR Text Key: 132354701
• Report Number: 1818910-2019-80136
• Device Sequence Number: 1
• Product Code: JDG
• 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: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention