MAUDE Adverse Event Report: ZIMMER, INC. MODULAR NECK G 12/14 NECK TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Corroded (1131)

Patient Problems Necrosis (1971); Nerve Damage (1979); Pain (1994); Swelling (2091); Tissue Damage (2104); Weakness (2145); Discomfort (2330); Osteolysis (2377); Reaction (2414); Metal Related Pathology (4530); Swelling/ Edema (4577)

Event Date 11/12/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant products: unk, unknown head, unk, 00771300600, modular femoral stem, unk, unk, unknown neck, unk, unk, unknown versys head, unk, unk, unknown trilogy liner, unk.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 06162.

Event Description

It was reported patient had a revision procedure two years post-implantation due to pain, discomfort, weakness, elevated metal ion levels, advanced local tissue reaction (altr), pseudotumor, and femoral nerve compression.Corrosion was found on the neck.Femoral stem was revised.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Concomitant medical products: 00771300600, mod ml taper fem st 6, 62350567, 00801803202, cocr femoral head, 62424313, 00620004822, shell porous with cluster holes 48 mm, 62435519, 00631004832, liner 10 degree elevated rim 32 mm, 62414741, 00625006540, bone scr 6.5x40 self-tap, 62412355, 00625006525, bone scr 6.5x25 self-tap, 62444791.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2018 - 00099, 0001822565 - 2017 - 06262.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant products: corrected the lot number of 00620004822, shell porous with cluster holes 48 mm, 62435619.

Event Description

It was reported that the patient had a revision procedure two years post-implantation due to pain, discomfort, weakness, elevated metal ion levels, advanced local tissue reaction (altr), pseudotumor, and femoral nerve compression.During the revision procedure, the surgeon noted extensive tissue damage and large pseudotumors as well as discoloration of the modular neck of the implants.During the same surgery, a second procedure was performed to decompress the femoral nerve that was encased in retroperitoneal swelling of the iliopsoas muscle due to altr.The liner was replaced while the stem, head, and neck were replaced with stryker product.The initial acetabular shell remained intact.No further event information available at the time of this report.

Manufacturer Narrative

Reported event was confirmed with operative notes provided.Revision op notes demonstrated that the patient was revised due to pain, pseudotumor, tissue damage and corrosion.The patient has a severe response with large tumor formation and destruction of muscle.Visible discoloration of the modular neck noted possibly from corrosion.Head and neck came off as one piece, stem removed without incident, shell well-fixed and left intact, liner removed.The surgeon did not shorten patient significantly because of the laxity of the abductors.The femoral nerve was found to be encased within the reactive tissue.Necrotic tissue noted without signs of infection or purulence.Tissue debrided and nerves decompressed without further complication.Device history records show no anomalies or deviations that would have affected the surgical outcome or contributed to the reported event.The additional information does not affect the root cause.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.

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 unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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.

Event Description

There is no update to the prior event description provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified signs of being implanted worn / foreign material for all devices.The head, neck, and stem was submitted for further analysis.Analysis determined a consensus modified goldberg score of 2.A score of 2 corresponds to fretting on more than one tenth of the surface and/or corrosion damage to one or more small areas for the neck and stem surfaces.Review of complaint history identified additional similar complaints for the head, no additional complaints for the neck and stem, and no additional complaints for the reported part and lot combinations.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Root cause unchanged.This complaint was confirmed based on the returned devices and medical records.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: MODULAR NECK G 12/14 NECK TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6842400
• MDR Text Key: 84814416
• Report Number: 0001822565-2017-06161
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/31/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00784802300
• Device Lot Number: 62422983
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 09/05/2017
• Supplement Dates Manufacturer Received: 01/14/2018; 06/25/2018; 05/30/2019; 11/13/2019; 01/30/2024
• Supplement Dates FDA Received: 02/13/2018; 06/25/2018; 06/26/2019; 11/20/2019; 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female