MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ6 STD OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Model Number 1570-01-120

Device Problems Loss of or Failure to Bond (1068); Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Necrosis (1971); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191); Muscle/Tendon Damage (4532); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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 manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.(b)(4).

Event Description

It was reported the patient had a hip replacement in 2014 that failed earlier this year.Patient is trying to find out if the parts that were used were recalled or should have not been used in combination.The part was depuy summit with a competitor titanium cup and cobalt chrome on polyethylene articulation.Patient could barely walk.After several tests , mris and bloods, the doctor said patient needed a new hip.Patient had high cobalt and chromium numbers in blood.Doi: 2014, dor: none reported, affected side: unknown.

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 manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Event Description

Medical records received, indicated that "primary surgery occurred (b)(6) 2014.Sticker sheets for primary implants are located within the sticker sheet attachment.The femoral side is depuy and the acetabular side is competitor.Revision operative notes (b)(6) 2020, indicate the patient received a right total hip revision, due to unspecified loosening, alval soft tissue reaction with chronic inflammation and necrotic tissue.And implant corrosion.It is noted, that the femoral head was worn with corrosion between the head junction of the stem.The surgery was completed without indication of complication by the surgeon".

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.Added: a2 (date of birth), a3, b1 (is product problem), b5, d4 (lot, udi, expiration date), d6a, d6b, h4 and h6 (clinical, impact and device codes).H6: clinical symptoms code: appropriate term/code not available, (e2402) used to capture blood heavy metal increased.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ6 STD OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10829421
• MDR Text Key: 215920507
• Report Number: 1818910-2020-24421
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295059370
• UDI-Public: 10603295059370
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1570-01-120
• Device Catalogue Number: 157001120
• Device Lot Number: 554987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 06/02/2022; 06/28/2022
• Supplement Dates FDA Received: 06/16/2022; 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ARTICULEZE M HEAD 36MM +12; COMPETITOR CUP (STRYKER); COMPETITOR HEAD (STRYKER); COMPETITOR LINER(STRYKER); COMPETITOR CUP (STRYKER); COMPETITOR HEAD (STRYKER); COMPETITOR LINER(STRYKER)
• Patient Outcome(s): Required Intervention
• Patient Sex: Female