MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET SIZE 1 130 MM STEM LENGTH; PROSTHESIS, HIP

Model Number N/A

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

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Age or date of birth: born in (b)(6).Udi: (b)(4).Concomitant medical products: part: 00-8114-001-00, femoral stem 12/14 neck taper standard offset size 1 130 mm stem length, lot: 63735436; part: 00801802230, femoral head 12/14 taper, lot: 63677745; part: p0463048, avan cmntd shell ss 48mm, lot: 0001105980; part: p0560048, avan insert 48/22, lot: 0001102705; part: 4711500396-1, optipac-s 60 refob bn cmt r, lot: b708c05355; part: 4711500693-1, optipac-s 60 refob bn cmt r, lot: a710b05615.Report source: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00630.

Event Description

It was reported that a patient underwent an initial left total hip arthroplasty and subsequently, the patient experienced redness and drainage from the surgical site.The patient was placed on prophylactic antibiotics, and was admitted for observation to rule out infection approximately two post-implantation.Infection was ruled out, and the drainage discontinued without further complication.Attempts have been made and no further information has been provided.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records.Medical records noted drainage from the surgical site with redness and poor approximation at the distal incision.A week later, there was a slight secretion from distal section of wound.After removing the sutures and monitoring for a few days without antibiotic treatment, the secretion stopped.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET SIZE 1 130 MM STEM LENGTH
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 8921461
• MDR Text Key: 155229110
• Report Number: 0002648920-2019-00629
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K960658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

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 Model Number: N/A
• Device Catalogue Number: 00811400100
• Device Lot Number: 63735436
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 58