MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ5 HI OFF; HIP FEMORAL STEM/SLEEVE

Catalog Number 157011110

Device Problems Corroded (1131); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problems Bruise/Contusion (1754); Fatigue (1849); Inflammation (1932); Pain (1994); Rash (2033); Swelling (2091); Tinnitus (2103); Tissue Damage (2104); Vertigo (2134); Blurred Vision (2137); Joint Swelling (2356); Depression (2361); Osteolysis (2377); Shaking/Tremors (2515); Weight Changes (2607); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)

Event Date 06/25/2015

Event Type  Injury  

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Litigation received.Litigation alleges pain, elevated metal ion levels, and clicking/popping.

Manufacturer Narrative

Conclusion and justification status for mdr: 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 investigation could not draw any conclusions regarding the reported event.Based on the inability to determine a root cause, the need for corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Manufacturer Narrative

(b)(4).

Event Description

Update 07/21/2016 - pfs and medical records received.After review of the medical records for mdr reportability, in addition to what was previously reported, the pfs reports blurred vision, instability, metal taste in mouth, swelling of ankles, tremors, skin rash, bruising, depression, vertigo, ringing in ears, fatigue, weight gain, heart burn.The medical records report osteolysis, acetabular cup loosening, metallosis and chronic inflammation.The revision surgery notes a loose acetabular cup and impingement of the cup against femoral neck.Part/lot numbers provided.Updated head/liner/stem and added cup.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.A search of the complaints databases identified other reports against the femoral head and liner.Per procedure, these devices are exempt from device history record review.A search of the complaints databases identified no other reports against the remaining product/lot code combinations.Medical records were reviewed.The investigation can draw no conclusions with the information provided.Based on the inability to determine root cause, the need for corrective action has not been indicated.Depuy still considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Ppf alleges metal wear.Doi: (b)(6)2005 - dor: (b)(6)2015 (right hip).

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary: no device associated with this report was received for examination.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.

• Brand Name: SUMMIT POR TAPER SZ5 HI OFF
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 5676702
• MDR Text Key: 45826456
• Report Number: 1818910-2016-19948
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K001991
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/21/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2010
• Device Catalogue Number: 157011110
• Device Lot Number: Z5BFW1000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2016
• Initial Date FDA Received: 05/24/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 12/18/2018; 06/16/2020
• Supplement Dates FDA Received: 06/30/2016; 08/16/2016; 09/24/2016; 12/20/2018; 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 109